BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX SV PTA CATHETER

    MDR report key: 1903848 · Received November 20, 2010

    Report

    Report Number
    9710478-2010-00140
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    AV-BERINGEN
    Product Code
    LIT
    PMA / PMN Number
    K081417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, THE REPORTED BALLOON RUPTURE COULD NOT BE CONFIRMED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITY WHICH COULD HAVE CONTRIBUTED TO THIS EVENT. IN-PROCESS INSPECTIONS AND TESTING MET MANUFACTURING CRITERIA. BASED ON THE AVAILABLE INFORMATION, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED BALLOON RUPTURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF A SHUNT, THE FOX SV BALLOON RUPTURED DURING INFLATION AT 2 ATMOSPHERES (ATM). A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT EFFECT. NO INFORMATION REGARDING BALLOON INTEGRITY OR BALLOON REMOVAL WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOX SV PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-BERINGEN 534295

    Patients

    Seq Age Sex Outcome Treatment
    1