BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WORKHORSE II BALLOON CATHETER

    MDR report key: 1060988 · Received June 12, 2008

    Report

    Report Number
    1319211-2008-00019
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 1, 2008
    Report Date
    June 9, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT HISTORY RECORD REVIEW: THE REPORTED LOT NUMBER WAS REVIEWED FOR ANY ABNORMALITIES, WHICH MAY HAVE CONTRIBUTED TO THE COMPLAINT. NOTHING WAS FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE SUB ASSEMBLY LOT HISTORY RECORDS WERE REVIEWED FOR ANY ABNORMALITIES THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT. NOTHING WAS FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. REVIEW OF RETURNED SAMPLE: THE COMPLAINT SAMPLE HAS NOT BEEN RETURNED FOR EVAL. CONCLUSION: THE COMPLAINT INVESTIGATION IS INCONCLUSIVE. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVAL. WITHOUT THE ACTUAL SAMPLE ANGIODYNAMICS IS UNABLE TO CONDUCT A THOROUGH INVESTIGATION. THE EXACT CAUSE OF THE COMPLAINT IS UNK. IT IS POSSIBLE THE BALLOON RUPTURE WAS CAUSED DUE TO OVER INFLATION. THE CATHETER IS LABELED FOR 18 ATM. A REVIEW OF THE MFG RECORDS FOR THE REPORTED LOT INDICATED THAT ALL OF THE DEVICE SPECIFICATION AND QUALITY REQUIREMENTS WERE SATISFIED. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION AT THIS TIME. FREQUENCY HAS INCREASED, BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.

    Description of Event or Problem · 1

    BALLOON AND CATHETER SNAPPED OFF AND SHEARED OFF INTO THE VESSEL. A SNARE HAD TO BE USED TO RETRIEVE THE BROKEN PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WORKHORSE II BALLOON CATHETER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY LIT ANGIODYNAMICS, INC. 940701

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR