BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC TREK CORONARY DILATATION CATHETER

    MDR report key: 3211234 · Received July 8, 2013

    Report

    Report Number
    2024168-2013-04268
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 13, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K110134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INNER MEMBER WAS SEPARATED IN THE MIDDLE OF THE PROXIMAL BALLOON MARKER, BUT THE SHAFT WAS STILL IN ONE PIECE. THE DIFFICULTY TO INFLATE THE BALLOON WAS ABLE TO BE CONFIRMED. BASED ON AN EXPANDED INVESTIGATION AND FURTHER REVIEW OF THE COMPLAINT HANDLING DATABASE AND OTHER SOURCES OF NONCONFORMITY DATA, IT WAS DETERMINED THAT ALTHOUGH THERE WAS NO RESISTANCE REPORTED WITH THE SHEATH REMOVAL, THE POSSIBLE CAUSE FOR THE FAILURE MODE COULD HAVE BEEN WITH DIFFICULTY IN REMOVING THE BALLOONS PROTECTIVE SHEATH. THE DATA SUGGESTED A POSSIBLE PRODUCT DEFICIENCY, WHICH REQUIRES PROCEDURAL CHANGES TO OPTIMIZE THE PROCESS IN MANUFACTURING. EFFECTIVENESS CHECKS WILL BE PUT IN PLACE MONITOR THE EFFECTIVENESS OF THE IMPLEMENTED CORRECTIVE AND PREVENTATIVE ACTIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A NON-CALCIFIED, MODERATELY TORTUOUS, LEFT ANTERIOR DESCENDING ARTERY STENTING PROCEDURE, A NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO ROUTINELY POST-DILATE A XIENCE XPEDITION STENT. WHEN THE NON-ABBOTT INFLATION DEVICE WAS INFLATED, THE BALLOON WOULD NOT INFLATE AT ALL. THE BDC WAS REMOVED AND THE SAME NON-ABBOTT INFLATION DEVICE WAS USED SUCCESSFULLY WITH A NEW NC TREK BDC TO COMPLETE THE PROCEDURE. THERE WERE NO ISSUES REPORTED WITH THE PREPARATION OF THE DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310581 NC TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30209G1

    Patients

    Seq Age Sex Outcome Treatment
    1 XIENCE XPEDITION STENT