MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number NI75TCDH

Device Problem Positioning Problem (3009)

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

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device on 24-apr-2023.The device evaluation was completed on 27-apr-2023.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and deflection evaluation of the returned device was performed following bwi procedures.Visual inspection was performed, and the peek housing component was found broken with exposed parts.Then, the deflection test was performed, and it was found within specifications.The damage observed on the peek housing could be related to the handling of the device after the procedure, however, this cannot be conclusively determined.A manufacturing record evaluation was performed for lot 30838461m, and no internal actions related to the reported complaint condition were identified.The 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.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.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 navi-star¿ thermo-cool¿ electrophysiology catheter and the biosense webster inc, (bwi) product analysis lab observed that the peek housing component was broken with exposed parts.Initially, it was reported that during the operation, the catheter was unable to deflect or relax completely.A second device was used to complete the operation.There was no adverse event reported on patient.The deflection issue is not mdr reportable.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found on 27-apr-2023 that the peek housing component was broken with exposed parts.This finding was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is 27-apr-2023.

• Brand Name: NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 16989163
• MDR Text Key: 315854587
• Report Number: 2029046-2023-01127
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835000559
• UDI-Public: 10846835000559
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NI75TCDH
• Device Catalogue Number: NI75TCDH
• Device Lot Number: 30838461M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2022
• 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: DEF 7.5F,TCNSTC,4P,D,252MM,HYP