MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL SMARTTOUCH; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D133601

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/05/2020

Event Type  malfunction  

Event Description

We are reporting a total of (b)(4) events with different models of electrophysiological ablation catheters by biosense webster, which occurred in the past year.In this report, we have listed 01 event out of the 41 events.The details are below: model/catalog #: d133601, lot number: 30417972m.Brand name: malfunction navistar thermocool catheters, broken spring mechanism.

• Brand Name: THERMOCOOL SMARTTOUCH
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 5110 commerce rd.; baldwin park CA 91706
• MDR Report Key: 11258059
• MDR Text Key: 229619284
• Report Number: 11258059
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D133601
• Device Catalogue Number: D133601
• Device Lot Number: 30417972M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1