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

Model Number D134702

Device Problems Break (1069); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2017

Event Type  malfunction  

Event Description

During the middle of the pulmonary vein isolation procedure for treatment of atrial fibrillation, there was a 402 error, "magnet interference" with the biosense thermocool smarttouch sf f-curve catheter.We changed to another stsf catheter ablation and received the same message and the handle for that ablation catheter broke.The last ablation catheter to be used was an st and worked.Manufacturer response for cardiac ablation percutaneous catheter, thermocool smarttouch sf (per site reporter).This is who the catheter issue was told to: (b)(4), territory manager, biosense webster (b)(4).

• Brand Name: THERMOCOOL SMARTTOUCH SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 6878475
• MDR Text Key: 86754935
• Report Number: 6878475
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2018
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR