MAUDE Adverse Event Report: BIOSENSE WEBSTER INC 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 Problem No Code Available (3191)

Event Date 10/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).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 30416515m, 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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient with history of wolff-parkinson-white (wpw) syndrome, repeated pseudo ventricular tachycardia (vt) and arrest, underwent a paroxysmal supraventricular tachycardia (svt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and developed complete atrioventricular (av) heart block requiring surgical intervention (pacemaker implantation).The patient entered the room with a temporary condition before the ablation treatment.After the ablation for septal kent, the patient developed complete av heart block.A pacemaker was implanted.There¿s no indication that prolonged hospitalization was required.Physician¿s opinion regarding the cause of the adverse event is that ablating at the septal kent might have caused the blockage.No bwi product malfunctions nor error messages were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

On (b)(6) 2021, biosense webster inc.Received additional information indicating the physician¿s opinion on the cause of this adverse event is that is was procedure related as they have ablated at the septal kent might have caused the blockage.Additionally it was reported the patient had been inserted temporary pace maker since before ablation procedure.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: 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: 10849256
• MDR Text Key: 217663436
• Report Number: 2029046-2020-01756
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30416515M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention