MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Ventricular Fibrillation (2130)

Event Date 09/27/2021

Event Type  Injury  

Event Description

It was reported that a (b)(6) female patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered ventricular fibrillation (vf) requiring direct cardio conversion.Atrial pacing from coronary sinus (cs) in a procedure with afib resulted in vf.After cardioversion, ventricular tachycardia (vt) and afib were repeated.Direct-current cardioversion (dc) did not return to sinus rhythm, but pulmonary vein isolation (pvi) was performed because hemodynamics was stable.Sinus rhythm was induced during ablation of the right pulmonary vein.Coronary angiogram (cag) was performed after pvi revealed coronary artery stenosis.After completion of the procedure, the patient awakened and had no problems with limb movement.This occurred when they started using the catheter.The physician commented that the patient had been treated with ¿pci¿ at another hospital from the beginning, and there was a high possibility that the patient had stenosis before ablation.When atrial pacing was introduced, the movement of the heart became poor and vf probably occurred.Not related to the thermocool® smart touch® sf bi-directional navigation catheter.Additional information received indicated the adverse event was discovered during use of biosense webster products.Intervention provided was direct cardio conversion.Patient outcome from the adverse event was reported as improved.The physician¿s opinion on the cause of this adverse event is that it was patient condition related.The pacing was planned and there was no unwanted pacing being delivered.

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30583889l number, and no internal action related to the complaint was found during the review.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).(b)(4).

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12694750
• MDR Text Key: 282841149
• Report Number: 2029046-2021-01822
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30583889L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 40 YR