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 06/01/2022

Event Type  malfunction  

Event Description

Device was prepped and flushed with heparinized saline but when it was plugged in to the generator an error appeared as a force sensor error.A new cable was tried, and device was unplugged plugged back in and flushed again, but the same error came up.So, a new device was used (same lot number) and worked fine.Patient was not affected.

• 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: 14799359
• MDR Text Key: 294676494
• Report Number: 14799359
• 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: 06/10/2022,06/07/2022

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: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30589230L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1