MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D133601

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrioventricular reentrant tachycardia (avrt) / wolff-parkinson-white (wpw) with a thermocool® smart touch¿ electrophysiology catheter and a deflection stuck issue occurred.It was reported that the catheter presents curve failure, which does not allow it to return to its upright position.The deflection could not be changed.The curve of the catheter was ¿semi-deflexed¿ and could not return to its upright state.The knob/piston could be pushed but when returned to its¿ original position, the curve was not removed.The failure occurred during the procedure, so it was difficult to remove it, but after several maneuvers of clockwise and counterclockwise turns, it was removed.There was not any ring, electrode, or other physical damage to the distal end of the catheter.There are no photographs available.No sheath was used because it was retro-aortic access.The procedure was not delayed, and it was successfully completed with no patient consequence.

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 22-jun-2022.The device evaluation was completed on 11-jul-2022.It was reported that a patient underwent an atrioventricular reentrant tachycardia (avrt) / wolff-parkinson-white (wpw) with a thermocool® smart touch¿ electrophysiology catheter and a deflection stuck issue occurred.It was reported that the catheter presents curve failure, which does not allow it to return to its upright position.The deflection could not be changed.The curve of the catheter was ¿semi-deflexed¿ and could not return to its upright state.The knob/piston could be pushed but when returned to its¿ original position, the curve was not removed.The failure occurred during the procedure, so it was difficult to remove it, but after several maneuvers of clockwise and counterclockwise turns, it was removed.There was not any ring, electrode, or other physical damage to the distal end of the catheter.There are no photographs available.No sheath was used because it was retro-aortic access.The procedure was not delayed, and it was successfully completed with no patient consequence.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection and deflection test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.The deflection issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.A manufacturing record evaluation (mre) was performed for lot # 30661070m and no internal actions related to the complaint were found during the review.Based on the mre, the d 4.Expiration date and h 4.Device manufacture date were updated.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14116752
• MDR Text Key: 290530146
• Report Number: 2029046-2022-00812
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

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 Expiration Date: 11/09/2022
• Device Model Number: D133601
• Device Catalogue Number: D133601
• Device Lot Number: 30661070M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 06/22/2022
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1