BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORKHORSE II PTA BALLOON CATHETER

    MDR report key: 4173242 · Received September 23, 2014

    Report

    Report Number
    1319211-2014-00129
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQY
    PMA / PMN Number
    K032069
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE DEVICE INVOLVED IN THE INCIDENT HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH.

    Description of Event or Problem · 1

    A PATIENT OF UNKNOWN AGE AND GENDER PRESENT FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. DURING THE PROCEDURE THE PTA BALLOON WAS DILATED TO 18-20 ATMS WHEN THE PHYSICIAN NOTED THAT THE BALLOON HAD BURST. THE FRACTURED PIECE WAS RETRIEVED FROM INSIDE OF THE PATIENT VIA SNARE, HOWEVER, THE PHYSICIAN SUSPECTED A PIECE STILL REMAINED INSIDE OF THE PATIENT. A GRAFT WAS LIGATED IN ORDER TO PREVENT EMBOLIZATION. THERE WAS NO REPORT OF PERMANENT HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590871 WORKHORSE II PTA BALLOON CATHETER PTA BALLOON CATHETER DQY ANGIODYNAMICS 601306

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention