BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 15757321 · Received November 8, 2022

    Report

    Report Number
    2029046-2022-02781
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Date of Event
    August 14, 2022
    Report Date
    November 8, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    UDI-DI
    10846835000559
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE ON (B)(6)2022 . THE DEVICE EVALUATION WAS COMPLETED ON (B)(6)2022 . VISUAL INSPECTION AND DEFLECTION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE PEEK HOUSING WAS CRACKED WITH EXPOSED WIRES. THE PEEK HOUSING DAMAGE COULD BE RELATED TO THE SHIPMENT PROCESS WHEN THE DEVICE WAS SENT IN FOR INVESTIGATION; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. A DEFLECTION TEST WAS PERFORMED, AND THE CURVE WAS DEFLECTING WITHIN SPECIFICATIONS. NO DEFLECTION ISSUES WERE OBSERVED. THE DEFLECTION 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 30755359M AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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: PC-(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB OBSERVED THAT THE PEEK HOUSING WAS FOUND CRACKED WITH EXPOSED WIRES. INITIALLY, IT WAS REPORTED THAT 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 THE PATIENT. THE DEFLECTION ISSUE WAS ASSESSED AS 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 VISUAL ANALYSIS REVEALED THAT THE PEEK HOUSING WAS FOUND CRACKED WITH EXPOSED WIRES. THIS FINDING WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS (B)(6)2022 .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2946549 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC NI75TCDH 30755359M 10846835000559

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK BRAND CATHETER