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

Model Number D132705

Device Problem Failure to Read Input Signal (1581)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2022

Event Type  malfunction  

Event Description

No signals on ablator on insertion into body.No patient harm.

• Brand Name: THERMOCOOL SMARTTOUCH
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive,; suite 200; irvine CA 92618
• MDR Report Key: 15842948
• MDR Text Key: 304098153
• Report Number: 15842948
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: (01)10846835009200(20)22
• 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: 11/11/2022

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: D132705
• Device Catalogue Number: D132705
• 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: 11/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 7300 DA
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Race: White