BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WORKHORSE II PTA BALLOON CATHETER

    MDR report key: 2192745 · Received June 28, 2011

    Report

    Report Number
    1319211-2011-00057
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQY
    PMA / PMN Number
    K032069
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED FOR EVAL WAS ONE USED WH II PTA CATHETER. A VISUAL REVIEW OF THE DEVICE NOTED THAT THE DEVICE WAS IN A COMPLETELY DEFLATED STATE. AN INFLATION DEVICE WAS CONNECTED TO THE Y-CONNECTOR AND AN ATTEMPT WAS MADE TO INFLATE THE BALLOON. THIS WAS UNSUCCESSFUL. THE COMPLAINT CANNOT BE CONFIRMED FOR "BALLOON FAILED TO DEFLATE" AS THE RETURNED DEVICE WOULD NOT INFLATE. A VISUAL REVIEW OF THE CATHETER SHAFT NOTED STRETCHING OF THE INNER LUMEN OF THE CATHETER SHAFT APPROX 3.3 CM DISTAL FROM THE BALLOON. THE OUTER TUBING OF THE SHAFT WAS DRAWDOWN ON THE INNER TUBING OF THE SHAFT. THE CATHETER SHAFT WAS THEN CUT AT THE DRAWDOWN. THE CROSS-SECTION WAS THEN VIEWED UNDER A MICROSCOPE. IT WAS NOTED THAT THE OUTER SHAFT WAS DRAWDOWN TO THE INNER SHAFT, THUS PREVENTING A PASSAGEWAY FOR DEFLATION. THE MOST LIKELY ROOT CAUSE FOR THE REPORTED COMPLAINT IS THAT THE END USER STRETCHED THE INNER SHAFT OF THE CATHETER WHILE REPOSITIONING THE BALLOON INSIDE THE PT OR THE END USER STRETCHED THE CATHETER SHAFT WHILE REMOVING PACKAGING MANDREL PRIOR TO USE. THE DRAWDOWN OF THE OUTER SHAFT ONTO THE INNER SHAFT WOULD ALLOW THE BALLOON TO INFLATE PROPERLY HOWEVER THE BALLOON WOULD NOT BE ALLOWED TO DEFLATE DUE TO THE COLLAPSED INFLATION LUMEN. DURING THE MFG PROCESSES ALL PTA BALLOONS ARE 100% INSPECTED FOR THIS FAILURE MODE. EACH BALLOON IS INFLATED, CHECKED FOR LEAKS AND THEN DEFLATED. DURING THE REVIEW OF THE MFG RECORDS FOR THE REPORTED LOT IT WAS OBSERVED THAT THE MANUFACTURED LOTS MET ALL DEVICE SPECS AND QUALITY REQUIREMENTS. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE END USER ON (B)(6) 2011. WHILE PERFORMING A THROMBECTOMY OF THE IMMATURE AV FISTULA, AFTER INFLATING THE PTA BALLOON TO 10ATMS IN THE OUTFLOW VEIN, THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON VIA THE INFLATION DEVICE. HE WAS UNABLE TO DO SO. THE BALLOON WAS RUPTURED WITH A 25 GAUGE NEEDLE AND DEFLATED USING A SYRINGE. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PT WITHOUT COMPLICATIONS. NO HARM OR INJURY WAS REPORTED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WORKHORSE II PTA BALLOON CATHETER PTA BALLOON CATHETER DQY ANGIODYNAMICS NA 542358

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention