BEUDAMED
    FDA Adverse Event Other Summary report: N

    REFORM (SILVERHAWK) PERIPHERAL CATHETER

    MDR report key: 488585 · Received October 7, 2003

    Report

    Report Number
    2954929-2003-00005
    Event Type
    Other
    Date Received
    October 7, 2003
    Date of Event
    September 24, 2003
    Report Date
    October 6, 2003
    Manufacturer
    FOX HOLLOW TECH. INC.
    Product Code
    MCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ILIAC BIFURCATION - DEVICE WAS PASSED UP THROUGH A STENT - LESION WAS IN THE PROXIMAL PART OF THE STENT (IN-STENT USE IS PROMINENTLY CONTRA-INDICATED IN THE INSTRUCTIONS FOR USE). OPERATOR MADE APPROXIMATELY 3 CUTTING PASSES WITH GOOD RESULTS. THE VESSEL WAS APPROXIMATELY 8MM (LARGER THAN LABELED MAX. EFFECTIVE TREATMENT RANGE). OPERATOR ATTEMPTED TO RESHAPE THE DISTAL END OF THE CATHETER TO EXTEND THE WORKING RANGE OF THE DEVICE. OPERATOR BELIEVES HE PUSHED THE DEVICE THROUGH THE STENT AND INTO THE BIFURCATION CAUSING THE PERFORATION WITH THE TIP/GUIDEWIRE RATHER THAN THE CUTTING ELEMENT. PERFORATION INITIALLY SEALED WITH BALLOON PRESSURE AND COVERED STENT. SHEATH LEFT IN AS A PRECAUTION. APPROXIMATELY 1-1 1/2 HOURS LATER PATIENT VOMITED REACTIVATING THE LEAK AT THE PERFORATION. PERFORATION COULD NOT BE CONTROLLED USING INTERVENTIONAL METHODS AND PATIENT WAS SENT TO SURGERY. PATIENT STABLE POST SURGERY. NO ALLEGATION OF DEVICE MALFUNCTION. IN-STENT USE CONTRA-INDICATED IN LABELING. OPERATOR ADMITTED ERROR IN JUDGEMENT USING DEVICE IN THIS CASE. DEVICE DESTROYED AT HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFORM (SILVERHAWK) PERIPHERAL CATHETER ATHERECTOMY, PERIPHERAL MCX FOX HOLLOW TECH. INC. 02200 03091606

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention