BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WORKHORSE II BALLOON CATHETER

    MDR report key: 872060 · Received June 25, 2007

    Report

    Report Number
    1319211-2007-00021
    Event Type
    Malfunction
    Date Received
    June 25, 2007
    Date of Event
    May 31, 2007
    Report Date
    June 26, 2007
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD REVIEW: THE LOT NUMBER WAS NOT PROVIDED. A SHIP HISTORY WAS CONDUCTED ON THE REPORTED CATALOG NUMBER BEING SHIPPED TO THE COMPLAINANT IN THE LAST 6 MONTHS. THE SHIP HISTORY SHOWED THE FOLLOWING LOTS HAD BEEN SENT: 923414, 923624, 924416, 925158, 925160, 925167, 925169, 928370, AND 928374. THE POSSIBLE LOT NUMBERS WERE REVIEWED FOR ANY ABNORMALITIES, WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT. NOTHING WAS FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. REVIEW OF RETURNED SAMPLE: THE COMPLAINT SAMPLE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RETURNED TO ANGIODYNAMICS FOR EVALUATION. ONCE THE SAMPLE HAS BEEN RETURNED AN EVALUATION WITH BE CONDUCTED. CONCLUSION: FINDINGS OF THE INVESTIGATION WILL BE REPORTED AT THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE BALLOON BUSTED AT THE SHAFT OF THE CATHETER. THE BALLOON AT THE DISTAL END OF THE CATHETER WAS IN TACT BUT ALL OF THE DAMAGE WAS AT THE PROXIMAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WORKHORSE II BALLOON CATHETER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER LIT ANGIODYNAMICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR