BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WORKHORSE II PTA BALLOON CATHETER

    MDR report key: 2192722 · Received July 11, 2011

    Report

    Report Number
    1319211-2011-00063
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ANGIODYNAMICS
    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 EVAL WAS ONE USED PTA BALLOON CATHETER. A VISUAL REVIEW OF THE DEVICE NOTED THAT THE BALLOON WAS IN A COMPLETELY DEFLATED STATE. IT WAS ALSO NOTED THE CATHETER SHAFT HAD TWO AREAS OF STRETCHING; ONE APPROX 1.7CM DISTAL FROM THE BALLOON AND APPROX (B)(4) AND THE SECOND WAS APPROX 5CM FROM THE BALLOON AND APPROX (B)(4) IN LENGTH. IN BOTH AREAS, THE OUTER TUBE OF THE CATHETER SHAFT APPEARED TO BE DRAWN DOWN ONTO THE INNER TUBE OF THE SHAFT, THUS PREVENTING A PASSAGEWAY FOR FLUID TO ALLOW THE BALLOON TO DEFLATE. THE CONDITION OF THE RETURNED DEVICE PREVENTED THE BALLOON FROM BEING INFLATED; HENCE THE BALLOON COULD NOT BE DEFLATED. THE COMPLAINT CANNOT BE CONFIRMED. 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 PT. 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 BY MFG PERSONNEL AND AQL INSPECTED BY QUALITY ASSURANCE 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 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 PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WORKHORSE II PTA BALLOON CATHETER PTA BALLOON CATHETER DQY ANGIODYNAMICS NA 536397

    Patients

    Seq Age Sex Outcome Treatment
    1