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

Catalog Number D133604IL

Device Problem Obstruction of Flow (2423)

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

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial tachycardia (at) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and the device (including port, luer hub) was not irrigating.An ablation alarm occurred which prevented further ablation.The catheter settings were proper.No pump issues were noted.A second device was used to complete the operation.There was no adverse event reported on patient.

Manufacturer Narrative

On (b)(6) 2024, the product investigation was completed.It was reported that a patient underwent an atrial tachycardia (at) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and the device (including port, luer hub) was not irrigating.An ablation alarm occurred which prevented further ablation.The catheter settings were proper.No pump issues were noted.A second device was used to complete the operation.There was no adverse event reported on patient.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, patency and irrigation test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.According to video provided by the customer, the device does not irrigate correctly; however, during the analysis in the lab, a patency and irrigation test were performed, and the device was flushing correctly, no obstructed holes were observed.No irrigation issues were observed.A manufacturing record evaluation was performed for the finished device 31141052m number, and no internal action related to the complaint was found during the review.The irrigation issue reported by the customer was confirmed based on the video provided by the customer.It should be noted that product failure is multifactorial.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18545996
• MDR Text Key: 333276680
• Report Number: 2029046-2024-00244
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D133604IL
• Device Lot Number: 31141052M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2023
• 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