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 Problems Bradycardia (1751); No Code Available (3191)

Event Date 07/14/2020

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.Investigation is in progress, once completed a supplemental will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(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 possibly suffered a sinus block requiring temporary pacemaker implantation.After pulmonary vein isolation (pvi) and mapping of the left atrium (la) with pentaray nav eco catheter, additional ablation was performed because an electric potential remained in the carina of the right pulmonary veins (rpv).At that time after additional ablation, only the junction came out, and the patient left the hospital by placing a temporary catheter.The patient was originally a patient with sick sinus, and the junction often came out even after stopping afib with intraoperative cardioversion (dc).There is no information about if extended hospitalization was required.The physician¿s commented that it was not a product defect, but additional ablation of the front side of the carina of rpv may have affected sinus in some way.There is a view that the disease will heal spontaneously after a certain number of days.Based on the event description it seems that the patient suffered a sinus block and is coded as ¿bradycardia¿.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available in the future; the reportability decision will be reassessed.

Manufacturer Narrative

On (b)(6) 2020, biosense webster inc.Received additional information about the patient and the event.It was reported the patient is male.It was also stated that no product malfunction was reported.Device evaluation details: the device investigation has been completed which included a manufacturing record evaluation (mre).The manufacturing record evaluation was performed for the finished device 30353214m number, and no internal action related to the complaint was found during the review.Since the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.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: 10382885
• MDR Text Key: 202233019
• Report Number: 2029046-2020-01017
• 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: 07/14/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30353214M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK_PENTARAY NAV ECO
• Patient Outcome(s): Other; Required Intervention