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

Model Number D134805

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2022

Event Type  malfunction  

Event Description

Device continued to show error message "contact force error".Trouble shooting was performed with md and vendor rep, and device continued to show error messages.No resolution of device malfunction.

Event Description

Device continued to show error message "contact force error".Trouble shooting was performed with md and vendor rep, and device continued to show error messages.No resolution of device malfunction.

• 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: 13598686
• MDR Text Key: 286120566
• Report Number: 13598686
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/18/2022

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: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30673744L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2022
• Date Report to Manufacturer: 02/25/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19451 DA