MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WITH THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Complete Heart Block (2627); No Code Available (3191)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device lot# 30349501m, and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Initial reporter phone: (b)(6).(b)(4).

Event Description

It was reported that a patient underwent atrial fibrillation (afib) ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered complete heart block requiring temporary pacemaker.During procedure atrial flutter (afl) was observed and cavotricuspid isthmus line ablation was performed.When the line was completed a complete atrioventricular (av) block was noticed.Since (av) conduction did not recover a temporary pacemaker was inserted and the operation ended.Later the caller was informed that the then av conduction returned, and the patient is making good progress.No information regarding extended hospitalization and physician¿s causality opinion was provided.

Manufacturer Narrative

Additional information was received on 9/23/2020.This adverse event was while creating an isthmus block line for afl.Ventricular pacing with temporary catheter was required.The patient¿s condition had improved.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: WITH THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10317778
• MDR Text Key: 200280204
• Report Number: 2029046-2020-00935
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30349501M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM (FOR JAPAN); CARTO 3 SYSTEM (FOR JAPAN)
• Patient Outcome(s): Required Intervention