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

Model Number D134805

Device Problems Defective Device (2588); Device Sensing Problem (2917); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2022

Event Type  malfunction  

Event Description

There was a temperature sensing issue with the ablation catheter after placement into the patient.The catheter was removed and replaced without incident or harm to the patient.Manufacturer notified and created pc-(b)(4).Several ablation catheters failed during this procedure.There were two ablation catheters that displayed an "invalid temp" and "current leak error".A 3rd ablation catheter was used successfully with no harm to the patient.Both ablation catheters were from the same lot.All same mfg and lot number.Manufacturer response for ablation catheter, thermocool smarttouch stsf (per site reporter) mfg rep notified and returned to mfg under pc-(b)(4).

• Brand Name: THERMOCOOL SMARTTOUCH SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 15715 arrow hwy.; irwindale CA 91706
• MDR Report Key: 14929465
• MDR Text Key: 295321916
• Report Number: 14929465
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/27/2022

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: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30739862L
• 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: 06/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other