BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONQUEST PTA BALLOON DILATATION CATHETER

    MDR report key: 4201086 · Received September 16, 2014

    Report

    Report Number
    2020394-2014-00423
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K083657
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE MFG REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNK. THE INVESTIGATION IS INCONCLUSIVE, AS THE SAMPLE WAS NOT RETURNED FOR EVAL. BASED ON THE AVAILABLE INFO, THE DEFINITIVE ROOT CAUSE IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON FAILED TO DEFLATE IN A LEFT ARM A/V FISTULA AFTER SEVERAL INFLATION HAD BEEN PERFORMED. A NEEDLE WAS INSERTED THROUGH THE SKIN TO DEFLATE THE BALLOON. DURING RETRACTION THROUGH THE SHEATH, THE PROXIMAL END OF THE BALLOON SEPARATED FROM THE CATHETER AND FOLDED OVER THE DISTAL TIP, HOWEVER, THE BALLOON CATHETER WAS REMOVED THROUGH THE SHEATH IN ITS ENTIRETY. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572409 CONQUEST PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention