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

Catalog Number D134805

Device Problem Mechanical Jam (2983)

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

Event Date 10/19/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the wire has broken in a full deflected position.Initially, it was reported that the ¿wire broke during right inferior pulmonary vein (ripv) bottom ablation¿.The damage did not result in wires and/or braid being exposed.The damage did not result in any lifted or sharp rings.The catheter was replaced, and the procedure was completed without patient consequence.This was initially assessed as non mdr reportable.However, on (b)(6) 2023, additional information was received stating that the wire has broken in a full deflected position.With the additional information received, this complaint is now considered mdr reportable product malfunction.The awareness date is (b)(6) 2023.

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the wire has broken in a full deflected position.Initially, it was reported that the ¿wire broke during right inferior pulmonary vein (ripv) bottom ablation¿.The damage did not result in wires and/or braid being exposed.The damage did not result in any lifted or sharp rings.The catheter was replaced, and the procedure was completed without patient consequence.This was initially assessed as non mdr reportable.However, on 09-nov-2023, additional information was received stating that the wire has broken in a full deflected position.With the additional information received, this complaint is now considered mdr reportable product malfunction.The awareness date is 09-nov-2023.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and deflection test of the returned device was performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Deflection test was performed, and the deflection mechanism failed specifications due to the puller wires, curve d and f, were found broken inside the handle.A manufacturing record evaluation (mre) was performed for the finished device 31103912l number, and no internal action to the complaint was found during the review.Based on the completed mre, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated with appropriate information.The issue reported by the customer was confirmed.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.This product issue will be addressed through bwi's quality system.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® 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
• 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: 18280451
• MDR Text Key: 329900904
• Report Number: 2029046-2023-02856
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31103912L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2023
• 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
• Treatment: AGILIS, S CURVE, 8.5 FR. SHEATH