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

Model Number D134804

Device Problem Device Sensing Problem (2917)

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

Event Date 06/22/2022

Event Type  malfunction  

Event Description

The catheter was prepped hooked up to the system and flushed the line and through.The device was not inserted into the patient due to a sensor error.New cable was switched out and the catheter was plugged back in (unplugged and plugged back in).Sensor error still continued.A new catheter was used (lot number 30799612l) and worked fine.

• 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: 15182559
• MDR Text Key: 297439518
• Report Number: 15182559
• 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: 07/15/2022,06/23/2022

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 Model Number: D134804
• Device Catalogue Number: D134804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1