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

Model Number D132705

Device Problem Device Sensing Problem (2917)

Patient Problem Insufficient Information (4580)

Event Date 12/28/2020

Event Type  malfunction  

Event Description

The temperature sensor was not functioning.The procedure was carried out without complications.From the procedural note: "access was gained to the right femoral vein using modified seldinger technique.The right femoral vein and artery were noted patent on ultrasound.Three separate punctures were made in the right femoral vein.One 9-french venous sheath, a long steerable sheath, biosense webster mobi, and a 5-french venous sheath advanced over guidewire in the right femoral vein.Through the right femoral vein, a decapolar catheter, st.Jude medical inquiry was advanced to the right atrium and the coronary sinus was cannulated.An ablation catheter, biosense-webster d/f smarttouch, and a 20-pole pentaray catheter were used for mapping and ablation.".

• Brand Name: THERMOCOOL SMARTTOUCH
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 5110 commerce rd; baldwin park CA 91706
• MDR Report Key: 11265426
• MDR Text Key: 229843998
• Report Number: 11265426
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: (01)10846835009200(17)211015(10)30456705M
• 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: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• 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
• Device Lot Number: 30456705M
• 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: 01/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Weight: 81