BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WORKHORSE II BALLOON CATHETER

    MDR report key: 956063 · Received April 27, 2007

    Report

    Report Number
    1319211-2007-00014
    Event Type
    Malfunction
    Date Received
    April 27, 2007
    Date of Event
    March 28, 2007
    Report Date
    April 27, 2007
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD REVIEW: THE LOT # WAS NOT REPORTED. A SHIP HISTORY WAS CONDUCTED ON THE REPORTED LOT # AND IT WAS FOUND THAT SEVERAL LOTS HAD BEEN SHIPPED TO THE COMPLAINANT IN THE LAST 12 MONTHS. THE FOLLOWING LOTS WERE SHIPPED: 915006, 915007, 917295, 917880, 917879, 917881, 918416, 919562, 921317, 921321, 921322, AND 923414. THE POSSIBLE LOT NUMBERS WERE REVIEWED FOR ANY ABNORMALITIES, NOTHING WAS FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. REVIEW OF RETURNED SAMPLE: THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR EVALUATION. CONCLUSION: THE COMPLAINT INVESTIGATION IS CURRENTLY ONGOING AT THIS TIME. FINDINGS OF THE INVESTIGATION WILL BE REPORTED AT THE CONCLUSION OF THE INVESTIGATION. FREQUENCY HAS INCREASED BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.

    Description of Event or Problem · 1

    AFTER PUNCTURING BALLOON, THE BALLOON SHEARED OFF AS IT WAS BEING PULLED OUT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1