BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WORKHORSE II PTA BALLOON CATHETER

    MDR report key: 1964218 · Received December 22, 2010

    Report

    Report Number
    1319211-2010-00051
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 13, 2010
    Report Date
    December 20, 2010
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQY
    PMA / PMN Number
    K032069
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE REPORTED COMPLAINT SAMPLE WAS DISPOSED OF BY THE END USER AND NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. THE ROOT CAUSE FOR THE REPORTED DEFECT IS UNK. THE INSTRUCTIONS FOR USE (IC 234), WHICH IS SUPPLIED TO THE END USER WITH THIS CATALOG NUMBER, CONTAINS A STATEMENT "IF RESISTANCE IS FELT UPON REMOVAL, THEN THE BALLOON, GUIDEWIRE AND THE SHEATH SHOULD BE REMOVED TOGETHER AS A UNIT, PARTICULARLY IF BALLOON RUPTURE OR LEAKAGE IS KNOWN OR SUSPECTED. THIS MAY BE ACCOMPLISHED BY FIRMLY GRASPING THE BALLOON CATHETER AND SHEATH AS A UNIT AND WITHDRAWING BOTH TOGETHER, USING A GENTLE TWISTING MOTION COMBINED WITH TRACTION." DURING THE REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED LOT, IT WAS OBSERVED THAT THE MANUFACTURED LOTS MEET ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS PRODUCT FAMILY AND FAILURE MODE. THIS TYPE OF COMPLAINT WILL CONTINUED TO BE MONITORED FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE DISTRIBUTOR IN (B)(4), THE PT WAS UNDERGOING A PROCEDURE FOR THE PLACEMENT OF THROMBOSED GRAFT. A PTA BALLOON WAS USED FOR VENOUS DILATION AND RUPTURED DURING INFLATION. AS A SYRINGE WAS USED FOR THE INFLATION AND NOT AN INFLATION DEVICE WITH A PRESSURE GAUGE, IT IS UNK AT WHAT PRESSURE THE BALLOON BURST. AS THE BALLOON WAS BEING REMOVED, A PORTION OF THE PLASTIC MATERIAL TORE OFF WHILE TRYING TO REMOVE THE BALLOON THROUGH THE A 7FR SHEATH. THE PHYSICIAN WHO WAS PERFORMING THE PROCEDURE ATTEMPTED TO EXTRACT THE MATERIAL WITH A SNARE DEVICE; HOWEVER WAS UNSUCCESSFUL. A SURGEON WAS REQUIRED TO PERFORM A CUT DOWN TO REMOVE THE PIECE OF BALLOON. THE PT IS STABLE AND NO FURTHER HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WORKHORSE II PTA BALLOON CATHETER PTA BALLOON CATHETER DQY ANGIODYNAMICS NA 525793

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention