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 Arrhythmia (1721); No Code Available (3191)

Event Date 10/16/2020

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 30422944m number, and no internal actions related to the complaint was found during the review.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial tachycardia (at) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered atrioventricular (av) heart block requiring surgical intervention (pacemaker implantation).After at mapping was conducted, ablation was being delivered in the right atrium (ra), which caused conduction block between the ra and left atrium (la).No bwi product malfunctions were reported.A pacemaker was implanted.Watchman device implantation was considered; however, no confirmation was received regarding this intervention.There¿s no indication that extended hospitalization was required.Patient¿s outcome is unknown.Physician¿s causality opinion was not provided.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available, it will be reviewed and processed accordingly.

Manufacturer Narrative

On 1/24/2021, additional information was received indicating the patient was male and the patient¿s condition has improved.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref#: (b)(4), it was noticed the h6.Type of investigation code b14 (analysis of production records) was inadvertently omitted in the 3500a initial medwatch report.

• 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: 10837226
• MDR Text Key: 216181017
• Report Number: 2029046-2020-01712
• 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: 10/16/2020

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: 08/16/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30422944M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 01/24/2021
• Supplement Dates FDA Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention