BEUDAMED
    FDA Adverse Event Other Summary report: N

    REFORM/SILVER HAWK CATHETER

    MDR report key: 546346 · Received September 23, 2004

    Report

    Report Number
    2954929-2004-00010
    Event Type
    Other
    Date Received
    September 23, 2004
    Date of Event
    August 12, 2004
    Report Date
    September 21, 2004
    Manufacturer
    FOX HOLLOW TECHNOLOGIES INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "TREATING THE MID ANTERIOR TIBIAL, NEARLY 100% STENOSED. 4 CM LESION. GREAT DIFFICULTY ACCESSING THE LESION. ONE INSERTION 2 SEQUENTIAL PASSES LATERAL, 2 SEQUENTIAL POSTERIOR. REMOVED DEVICE, WHEN INJECTING CONTRAST NOTICED PERFORATION AT MID ANTERIOR TIBIAL. FOLLOWED WITH BALLOON INFLATION, PT PRESSURE FINE, PERF RESOLVED. PHYSICIAN DID NOT FEEL THERE WAS A DEVICE MALFUNCTION OR COMPLICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFORM/SILVER HAWK CATHETER PERIPHERAL ATHERECTOMY MCW FOX HOLLOW TECHNOLOGIES INC. 04300 04070812

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention