BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORKHORSE II PTA BALLOON CATHETER

    MDR report key: 2884893 · Received December 7, 2012

    Report

    Report Number
    1319211-2012-00248
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQY
    PMA / PMN Number
    K032069
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 REPORTED DEFECT DEVICE HAS BEEN RETURNED TO THE MFR. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION AND ANY F/U INFO WILL BE SENT VIA A F/U MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED (B)(6) 2012, THE FIRST WEEK OF (B)(6) 2012, PT OF UNK GENDER AND AGE PRESENTED FOR AN ANGIOPLASTY PROCEDURE. DURING THE PROCEDURE, AFTER THE PTA BALLOON WAS INFLATED TO 8-10ATM, THE PTA BALLOON RUPTURED IN THE PT'S POPLITEAL VEIN. THE TREATING PHYSICIAN WAS ABLE TO SUCCESSFULLY RETRIEVE AND REMOVE THE BALLOON FROM THE PT USING A SNARE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PT WAS REPORTED TO BE DOING WELL AFTER THE F/U VISIT WITH THE TREATING PHYSICIAN. THERE IS NO REPORTED HARM OR INJURY TO THE PT DUE TO THIS EVENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MFR FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WORKHORSE II PTA BALLOON CATHETER PTA BALLOON CATHETER DQY ANGIODYNAMICS 512524

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention