MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number NI75TCDH

Device Problems Break (1069); Positioning Problem (3009)

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

Event Date 05/13/2023

Event Type  malfunction  

Manufacturer Narrative

The photo analysis and product investigation was completed.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the tip was observed not deflected with the piston up.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 inspection was performed, and the peek housing was observed broken from the tip.Then, a deflection test was performed, and the deflection mechanism failed specifications due to the puller wire was found broken on the shaft.It was concluded that the peek housing damage could be related to excessive force after the procedure, however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 30929989m number, and no internal actions related to the reported complaint condition were identified.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.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 unspecified ablation procedure with a navistar¿ electrophysiology catheter and post procedure the bwi product analysis lab identified that the peek housing was broken from the tip.During the procedure, 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 broken peek housing is mdr-reportable.

• Brand Name: NAVISTAR¿ 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: 17690632
• MDR Text Key: 322734418
• Report Number: 2029046-2023-02002
• 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: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NI75TCDH
• Device Lot Number: 30929989M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2022
• 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