BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCUTRAK PTA BALLOON DILATATION CATHETER

    MDR report key: 1958779 · Received January 7, 2011

    Report

    Report Number
    2020394-2011-00007
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K082343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MFG PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE IS NOTHING SEEN IN THE DHR TO INDICATE THAT THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR CORPORATE LOT NUMBER 100707-1. THE DEVICE HAS NOT BEEN RETURNED TO THE MFR TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON FAILED TO DEFLATE AFTER THE FIRST INFLATION WITHIN A STENT. REPORTEDLY, THE PTA BALLOON DILATATION CATHETER WAS BEING USED FOR IN STENT STENOSIS WITHIN THE SFA. THE BALLOON WAS INFLATED ONCE AT 6 ATMS WITHIN THE STENT AND WOULD NOT DEFLATE. THE BALLOON WAS PUNCTURED THROUGH THE SKIN WITH A SYRINGE AND THE BALLOON CATHETER WAS REMOVED THROUGH THE SHEATH WITHOUT FURTHER INCIDENT. ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCUTRAK PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. 100707-1

    Patients

    Seq Age Sex Outcome Treatment
    1