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

Model Number D132705

Device Problem Device Sensing Problem (2917)

Patient Problem Insufficient Information (4580)

Event Date 02/11/2020

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 (b)(4) event out of the (b)(4) events.The details are below: brand name: smart touch bi-directional catheter.Model/catalog #: d132705, lot number: 30280891m, malfunction: malfunction: 106 force sensor error.D132705, 30283510m, map sensor error.

• 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: 11258063
• MDR Text Key: 229619621
• Report Number: 11258063
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30280891M AND 30283510M
• Was Device Available for Evaluation?: No
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1