BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WORKHORSE II PTA BALLOON CATHETER

    MDR report key: 2223923 · Received July 11, 2011

    Report

    Report Number
    1319211-2011-00064
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DQY
    PMA / PMN Number
    K032069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED FOR EVALUATION WAS ONE USED PTA BALLOON CATHETER. A VISUAL REVIEW OF THE CATHETER SHAFT NOTED AN AREA OF STRETCHING APPROXIMATELY 5.3 CM FROM THE BALLOON AND APPROXIMATELY 7 MM IN LENGTH. AN INFLATION DEVICE WAS CONNECTED TO THE Y-CONNECTOR AND AN ATTEMPT WAS MADE TO INFLATE THE BALLOON. THE BALLOON WAS EASILY INFLATED TO 16ATMS. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON. THIS ATTEMPT WAS UNSUCCESSFUL. THE COMPLAINT IS CONFIRMED. AT THE SITE OF THE STRETCHING, THE OUTER TUBE OF THE SHAFT WAS DRAWN DOWN ON THE OUTER TUBE OF THE CATHETER SHAFT, THUS PREVENTING A PASSAGEWAY FOR FLUID TO ALLOW THE BALLOON TO DEFLATE. THE MOST LIKELY ROOT CAUSE FOR THE REPORTED COMPLAINT IS THAT THE END USER STRETCHED THE OUTER SHAFT OF THE CATHETER WHILE REPOSITIONING THE BALLOON INSIDE THE PATIENT. 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 LUMEN INFLATION LUMEN. DURING THE MANUFACTURING PROCESSES ALL PTA BALLOONS ARE 100% INSPECTED BY MANUFACTURING PERSONNEL AND (B)(4) INSPECTED BY (B)(4) FOR THIS FAILURE MODE. EACH BALLOON IS INFLATED, CHECKED FOR LEAKS AND THEN DEFLATED. DURING THE REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED LOT IT WAS OBSERVED THAT THE MANUFACTURED LOTS MET ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS. A REVIEW OF THE (B)(4) 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 USER ON (B)(6) 2011, AFTER SUCCESSFULLY COMPLETING PROCEDURE USING A PTA BALLOON, THE BALLOON WOULD NOT DEFLATE. IN ORDER TO FULLY DEFLATE THE BALLOON IT WAS PULLED BACK TO THE VASCULAR ACCESS AND PUNCTURED WITH A NEEDLE AND DEFLATED. THE BALLOON WAS REMOVED SUCCESSFULLY WITH NO COMPLICATIONS TO THE VASCULAR ACCESS. THERE WAS NO HARM OR INJURY REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WORKHORSE II PTA BALLOON CATHETER PTA BALLOON CATHETER DQY ANGIODYNAMICS, INC. NA 536409

    Patients

    Seq Age Sex Outcome Treatment
    1