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

Model Number D133601 AND D133602

Device Problems Signal Artifact/Noise (1036); Break (1069); Mechanical Problem (1384); Failure to Zero (1683); Communication or Transmission Problem (2896); Device Sensing Problem (2917); Positioning Problem (3009); Temperature Problem (3022); Erratic Results (4059)

Patient Problem Insufficient Information (4580)

Event Date 12/04/2020

Event Type  malfunction  

Event Description

We are reporting a total of 41 events with different models of ablation catheters by biosense webster, which occurred in the past year.In this report, we have listed 18 events out of the 41 events.Out of the 18 events, 14 are related to product model/catalog# d133601 and 4 are related to product model/catalog# d133602.The details of each event are listed below.Brand name: thermocool smarttouch lot number: model/catalog#: error code: 30273116m d133601 106 force sensor error.30273116m d133601 temperature sensor error.30293973m d133602 bad/partial ecg.30318154m d133602 no temperature reading.30339205m d133601 no temperature reading.30359432m d133601 high force, unable to zero.30369189m d133601 broken spring mechanism.30377529m d133601 noisy signals.30377537m d133601 105 magnetic sensor error.30383968m d133601 lost ability to deflect.30383969m d133601 erratic temperature readings.30383969m d133601 lost ability to deflect.30383969m d133601 unable to curve.30387224m d133601 high temps.30401562m d133601 106 force sensor error.30401562m d133601 unable to deflect.30401608m d133602 broken steering mechanism.30440520m d133602 no signal poles 3 and 4.

• 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: 11250795
• MDR Text Key: 229333163
• Report Number: 11250795
• 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: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D133601 AND D133602
• Device Catalogue Number: D133601 AND D133602
• 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: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1