BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOW-DIRECTED BALLOON CATHETER

    MDR report key: 2872682 · Received December 6, 2012

    Report

    Report Number
    1820334-2012-00554
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 8, 2012
    Manufacturer
    COOK, INC.
    Product Code
    DYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT: REMOVAL OF FOREIGN BODY IS NOT LABELED. DEVICE: INFLATION/DEFLATION AND BALLOON RUPTURE IS ADDRESSED IN THE IFU. PRODUCT WAS RETURNED IN A USED AND DAMAGED CONDITION. DURING THE INVESTIGATION, A REVIEW OF COMPLAINT HISTORY, REVIEW OF THE PROVIDED INSTRUCTIONS FOR USE, A REVIEW OF QUALITY CONTROL SPECIFICATION, REVIEW OF TRENDS, AND A VISUAL INSPECTION OF THE RETURNED PRODUCT WERE PERFORMED. PER QUALITY CONTROL SPECIFICATION, THERE IS VERIFICATION THAT THE BALLOON DEFLATES PROPERLY. IN ADDITION, THE PROVIDED IFU STATES "USE ONLY BACTERIA FILTERED CARBON DIOXIDE FOR BALLOON INFLATION." AN EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE INFLATION PORT WAS PRESENT, BUT MOST OF THE BALLOON WAS ABSENT, MOST LIKELY DUE TO THE DIFFICULTY IN REMOVAL. THE EVENT DESCRIPTION STATES THAT DEFLATION WAS ATTEMPTED "ON THE 3RD PASS OF THE BALLOON CATHETER BEING INSERTED AND DRAWN BACK, THE BALLOON WOULD NOT DEFLATE." BY THE 3RD PASS CONTRAST MAY HAVE HARDENED WITHIN THE CATHETER PREVENTING DEFLATION. THIS WAS AN OFF LABEL USE FOR THIS DEVICE AS STATED IN THE EVENT DESCRIPTION. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. INSUFFICIENT RISK PER QUALITY ENGINEERING RISK ASSESSMENT.

    Description of Event or Problem · 1

    INFORMATION PROVIDED THAT THE USER PUT THE BALLOON INTO THE FISTULA. THEY USED A 1 CC SYRINGE TO INFLATE THE BALLOON. WHILE THE BALLOON IS IN THE FISTULA, THEY SLOWLY DRAW THE CATHETER BACK TOWARD THE SHEATH. WHEN THE BALLOON CATHETER IS CLOSE TO THE TIP OF THE ACCESS SHEATH, THEY ASPIRATE THE BLOOD AND EMBOLI THROUGHOUT THE SHEATH INTO THE SYRINGE. THEY DO THIS TO COLLECT THE EMBOLI THAT THEY BELIEVE IS IN THE FISTULA. ON THE 3RD PASS OF THE BALLOON CATHETER BEING INSERTED AND DRAWN BACK, THE BALLOON WOULD NOT DEFLATE AND THEY DID NOT KNOW WHAT TO DO. THEY COULD NOT GET THE CATHETER OUT BECAUSE THE BALLOON WOULD NOT DEFLATE. THEY TRIED TO PULL THE BALLOON BACK INTO THE SHEATH BUT IT WOULD NOT WORK. THEY PULLED HARD ENOUGH ON THE CATHETER THAT THE BALLOON POPPED ON THE END OF THE SHEATH. THE FURTHER PROBLEM IS THAT A PIECE OR PIECES OF THE BALLOON REMAINED IN THE FISTULA. SUBSEQUENTLY, THEY CUT OUT THE FISTULA AND PUT IN A NEW FISTULA IN ORDER TO REMOVE THE FRAGMENTS. THE PHYSICIAN IS AWARE THAT THE DEVICE WAS BEING USED IN A NON-INDICATED WAY. THE BALLOON WAS INJECTED WITH A 50/50 SALINE TO CONTRAST MIXTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOW-DIRECTED BALLOON CATHETER DYG CATHETER, FLOW DIRECTED DYG COOK, INC. NA 3379204

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention