MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D133603
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a male patient underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter.The patient suffered transient heart block requiring temporary transvenous pacing (tvp).It was reported a patient suffered a transient heart block.They were mapping the avnrt with the pentaray catheter, both the fast and slow pathways and towards the end of the procedure, when they were ablating, they noticed the heart block.They came off ablation and began right ventricle (rv) pacing "to get the heart going again." they got the heart stable enough to put in a temporary pacemaker after which the heart returned to a normal sinus rhythm.The patient was stable and all intervals associated with the sinus rhythm were normal when he and the physician left the room.The patient will stay overnight for observation.The case was not part of a clinical study.The caller asked the physician what their opinion was of the cause and the physician indicated that during ablation, the catheter slipped and bumped the fast pathway but did not ablate it, which is why the sinus rhythm returned.Additional information was received on the event.This adverse event was discovered during use of biosense webster products.Temporary transvenous pacing (tvp) was performed as intervention.The patient outcome of the adverse event is fully recovered.Other relevant history includes low ef.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14880762
• Report Number: 2029046-2022-01490
• Device Sequence Number: 17434136
• Product Code: LPB
• UDI-Device Identifier: 10846835009019
• UDI-Public: 10846835009019
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: D133603
• Device Catalogue Number: D133603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERIC - PENTARAY; SMARTABLATE GENERATOR KIT-US; WEBSTER CORONARY SINUS CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male