BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FATHOM GUIDEWIRE

    MDR report key: 1612982 · Received February 23, 2010

    Report

    Report Number
    2939204-2010-00254
    Event Type
    Injury
    Date Received
    February 23, 2010
    Date of Event
    January 27, 2010
    Report Date
    January 27, 2010
    Manufacturer
    SALT LAKE CITY
    Product Code
    DQX
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K050964. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. PHYSICAL ANALYSIS OF THE SUBJECT DEVICE REVEALED THAT THE GUIDEWIRE WAS SEPARATED AT ITS DISTAL SECTION AT 298.2CM FROM ITS PROXIMAL END. THE COREWIRE, NITINOL TUBING AND PLATINUM COIL WERE SEPARATED AT APPROXIMATELY 1.8CM FROM ITS DISTAL END. THE SEPARATED END OF THE GUIDEWIRE WAS NOT RETURNED. THE NITINOL TUBING WAS CUT TO EXPOSE THE CORE WIRE, AND NO NITINOL TUBING STRETCHING WAS OBSERVED. THE PROXIMAL SECTION OF THE GUIDEWIRE DID NOT REVEAL ANY PEELING/FLAKING OF THE POLYTETRAFLUOROETHYLENE (PTFE) COATING. BASED ON THE INFORMATION AVAILABLE, THE PHYSICIAN USED AN OVER THE WIRE CROSS CATHETER WHICH USES HIGH-FREQUENCY VIBRATION TO FACILITATE NAVIGATION OF GUIDEWIRES BEYOND TOTAL CHRONIC OCCLUSIONS. DURING USE OF THE CROSS CATHETER, THE GUIDEWIRE SHOULD NEVER BE IN FRONT OF THE PULSATING PORTION. HOWEVER, IN THE REPORTED EVENT, THE GUIDEWIRE WAS ADVANCED AHEAD OF THE PULSATING PORTION RESULTING IN THE GUIDEWIRE BREAKAGE. THEREFORE, THE CAUSE OF THE REPORTED EVENT WAS USE/USER ERROR.

    Description of Event or Problem · 1

    DURING A PROCEDURE BOTH GUIDEWIRES WERE POSITIONED AHEAD OF THE TOTAL OCCLUSION DEVICE. WHEN THE PULSATING PORTION OF THE TOTAL OCCLUSION DEVICE CAME INTO CONTACT WITH THE GUIDEWIRES THEY BOTH BROKE IN THE MID PORTION OF THE SUPERIOR FEMORAL ARTERY. THE FIRST GUIDEWIRE HAD THE NITINOL HYPOTUBE SHEERED OFF AND BECAME STUCK IN THE VESSEL. A STENT WAS PLACED IN THE RIGHT SUPERIOR FEMORAL ARTERY TO SECURE THE BROKEN PORTION OF THE HYPOTUBE AGAINST THE VESSEL WALL. THE PHYSICIAN WAS ABLE TO RETRIEVE THE SECOND GUIDEWIRE (SUBJECT DEVICE) WITH THE USE OF A SNARE. THE PROCEDURE WAS COMPLETED AND THE PATIENT IS REPORTEDLY DOING FINE.

    Description of Event or Problem · 1

    DURING A PROCEDURE BOTH GUIDEWIRES WERE POSITIONED AHEAD OF THE TOTAL OCCLUSION DEVICE. WHEN THE PULSATING PORTION OF THE TOTAL OCCLUSION DEVICE CAME INTO CONTACT WITH THE GUIDEWIRES THEY BOTH BROKE IN THE MID PORTION OF THE SUPERIOR FEMORAL ARTERY. THE FIRST GUIDEWIRE HAD THE NITINOL HYPOTUBE SHEERED OFF AND BECAME STUCK IN THE VESSEL. A STENT WAS PLACED IN THE RIGHT SUPERIOR FEMORAL ARTERY TO SECURE THE BROKEN PORTION OF THE HYPOTUBE AGAINST THE VESSEL WALL. THE PHYSICIAN WAS ABLE TO RETRIEVE THE SECOND GUIDEWIRE (SUBJECT DEVICE) WITH THE USE OF A SNARE. THE PROCEDURE WAS COMPLETED AND THE PATIENT IS REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FATHOM GUIDEWIRE WIRE, GUIDE, CATHETER DQX SALT LAKE CITY UNK171

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CROSSER 14 CATHETER (FLOWCARDIA)| FATHOM GUIDEWIRE (BOSTON SCIENTIFIC)