188体育

滨苍迟谤辞诲耻肠迟颈辞苍听听

This document provides guidance for manufacturers of devices for cardiac ablation. It outlines specific scenarios to consider when determining if an incident is reportable.聽聽

You should read this document in conjunction with guidance on post-market surveillance.

The aim of this guidance is to complement the requirements of . You should read it in conjunction with this regulation. Device-specific guidance does not replace or extend these requirements.聽

What to report聽

The following examples indicate how to report device performance problems that caused or contributed to an incident. The examples are for illustrative purposes only and do not constitute an exhaustive list. If an incident appears to meet criteria contained in more than one category, ensure it is included in submissions under each reporting format, even if this results in duplication of reporting for that incident.聽

1. Report as individual incidents (in line with statutory timescales)聽

The IMDRF Annex A and E codes associated with each text description are included as guides in the following:聽

Clinical / symptomatic:聽

• device may have contributed to death or serious deterioration in health and link to a possible device malfunction unknown within reporting timeframes E060106聽

顿别惫颈肠别:听

• ablation catheter introduction or withdrawal issues A150206 / A150207 / A0406 / A1502 / A150204 / A1702 / A040601 / A040609聽

• mechanical problem with ablation catheter (for example, tip fracture, entrapment of multipolar ablation catheters) A0413 / A040101 / A150208 / A1503 / A0406 / A0411 / A0501 / A0404 / A0401 / A040609 / A05 / A041001聽

• incidents relating to ablation accessories or equipment failure A12聽

• ablation energy delivery problems A1003 / A1004 / A072102 / A090807 / A0709 / A072202 / A0722 / A090402聽

• excessive coagulum appearance on the ablation catheter electrode or distal shaft of the catheter A180103 / A0702聽

• excessive ablation electrode charring as defined by the operating clinician or user A180103聽

• saline or medium leak (for example, cryo fluid) A050401聽

• cardiac ablation system parameter anomalies (for example, temperature or impedance value, alarm or display warning malfunction) which result in patient injury A090807 / A0908 / A090808 / A070908 / A090205聽

• failure to deliver pacing energy A071204 / A0712聽

2. Incidents that may be included in periodic summary reports (PSR) on agreement聽

If you cannot use PSR, then report these events individually:聽

• post FSCA adverse incidents - reporting periodicity as agreed with the MHRA聽

3. Report at the time of a significant increase in the frequency or severity of incidents:聽

• All reportable adverse incidents聽

The IMDRF Annex A and E codes associated with each text description are included as guides in the following:聽

Clinical / symptomatic:聽

• stroke with an onset of symptoms within 72 hours of the procedure E0133聽

• myocardial infarction with an onset of symptoms within 72 hours of the procedure E061202聽

• transient ischaemic attack with an onset of symptoms within 72 hours of the procedure E0137聽

• pulmonary embolism with an onset of symptoms within 72 hours of the procedure E050303聽

• cardiac perforation / pericardial effusion / tamponade E0604 / E0605 / E0619聽

• unexplained death or serious injury E0623聽

• phrenic nerve paralysis with an onset of symptoms within 72 hours of the procedure E0123 / E012202聽

• collateral tissue damage, for example, damage to oesophagus or other non-intended tissue damage following ablation E0621 / E062102聽

• angina exacerbation with an onset of symptoms within 72 hours of the procedure E061201 / E233001聽

• cardiac pacing issues encountered during the procedure, which did not require intervention to mitigate serious injury or death E060104 / E060109 / E0618 / E0601 / E060101 / E060102聽

顿别惫颈肠别:听

• coagulum (non-excessive) appearance on the ablation catheter electrode or distal shaft of the catheter ablation electrode charring (non-excessive) A180103聽

• ablation popping