BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3010401 · Received March 19, 2013

    Report

    Report Number
    9673241-2013-00069
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DURING THE RVOT PROCEDURE IT WAS REPORTED THE PHYSICIAN WAS NOT ABLE TO EXTEND THE CATHETER INTO A STRAIGHT POSITION. CATHETER WAS STUCK IN A BENT SHAPE. THIS CATHETER WAS REPLACED WITH A NEW CATHETER, THE NEW CATHETER WAS WORKING FINE. ADDITIONAL INFORMATION PROVIDED STATED THERE WAS NO DIFFICULTY REMOVING THE CATHETER FROM THE PATIENT. THE CATHETER WAS PLACED IN THE RIGHT VENTRICLE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT¿S CONSEQUENCE. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND THAT THE TIP WAS BENT AT 2.2 CM FROM THE TRANSITION ARE. DEFLECTION TESTS WERE PERFORMED AND THE CATHETER PASSED DEFLECTION AND PRE-CURVE TESTS. THE CATHETER DID NOT GET STUCK IN THE DEFLECTED POSITION. THE CATHETER FAILED THE TIP TILT TEST DUE TO THE BENT AT 2.2 CM FROM THE TRANSITION AREA. THE CATHETER WAS OBSERVED UNDER X-RAYS AND THE PULLER WIRE WAS NOT FOUND BENT OR DAMAGED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. IN ADDITION, ALL THE CATHETERS ARE INSPECTED FOR VISUAL DAMAGES BEFORE PACKAGING. ON LINE INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGE/DEFECT FROM LEAVING THE FACILITY. THE CUSTOMER COMPLAINT REGARDING THE CATHETER GETTING STUCK ON DEFLECTED POSITION CANNOT BE CONFIRMED; HOWEVER, DURING THE INVESTIGATION A SLIGHT BENT ON THE TIP WAS OBSERVED BUT A ROOT CAUSE COULD NOT BE DRAWN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING THE RVOT PROCEDURE IT WAS REPORTED THE PHYSICIAN WAS NOT ABLE TO EXTEND THE CATHETER INTO A STRAIGHT POSITION. CATHETER WAS STUCK IN A BENT SHAPE. THIS CATHETER WAS REPLACED WITH A NEW CATHETER, THE NEW CATHETER WAS WORKING FINE. ADDITIONAL INFORMATION PROVIDED STATED THERE WAS NO DIFFICULTY REMOVING THE CATHETER FROM THE PATIENT. THE CATHETER WAS PLACED IN THE RIGHT VENTRICLE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT'S CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114453 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-16-S 15577779M

    Patients

    Seq Age Sex Outcome Treatment
    1