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 Problems Material Twisted/Bent (2981); Positioning Problem (3009)

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

Event Date 03/13/2023

Event Type  malfunction  

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 was cracked with internal parts exposed.Initially, it was reported that during the operation, the catheter was unable to deflect or relax completely.The tip of the catheter was found bent a second device was used to complete the operation.There was no adverse event reported on patient.The deflection and bent tip issues were assessed as not mdr reportable.The potential 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 12-may-2023 that the peek housing was cracked with internal parts exposed.This finding was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is 12-may-2023.

Manufacturer Narrative

A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the tip was observed with a bent condition.However, the photo did not provide sufficient information related to the deflection issue and therefore no results can be obtained from it.The navi-star¿ thermo-cool¿ electrophysiology catheter was returned to biosense webster (bwi) for evaluation on (b)(6) 2023.The device evaluation was completed on 12-may-2023.Visual inspection and deflection test of the returned device were performed following bwi procedures.Visual analysis revealed that the peek housing was cracked with internal parts exposed.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.The root cause of the peek housing cracked could be related to the handling of the device during the procedure.The bent condition observed on the picture provided by the customer is related to the peek housing damage observed on the device.A manufacturing record evaluation was performed for the finished device 30898643m number, and no internal action was found during the review.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.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the peek housing cracked with exposed parts.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported deflection issue.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the peek housing cracked with exposed parts.H6.Investigation findings code of "appropriate term/code not available" represents photo/video analysis.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).

• 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: 17080820
• MDR Text Key: 317174773
• Report Number: 2029046-2023-01249
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• 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: 30898643M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2023
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2022
• 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