BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THROMCAT THROMBECTOMY CATHETER

    MDR report key: 1002799 · Received February 26, 2008

    Report

    Report Number
    2530154-2008-00001
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    January 21, 2008
    Report Date
    February 26, 2008
    Manufacturer
    KENSEY NASH CORP.
    Product Code
    MCW
    PMA / PMN Number
    K060016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THE DEVICE RECEIVED THE CE MARK FOR USE IN CORONARY AND PERIPHERAL ARTERIES. THE TARGET VESSEL FOR THIS PROCEDURE WAS A CORONARY SAPHENOUS VEIN BYPASS GRAFT. CONCLUSION: THE DEVICE IFU CONTAINS A WARNING FOR THE USER TO AVOID ADVANCING THE DEVICE AGAINST RESISTANCE AND THE IFU CONTAINS A PRECAUTION INSTRUCTING THE USER NOT TO FORCEFULLY ADVANCE THE CATHETER. ROOT CAUSE: THE MOST PROBABLE ROOT CAUSE IS THAT THE PHYSICIAN WAS PUSHING AGAINST RESISTANCE AND UNSEATED THE GUIDE CATHETER. THIS POSSIBLY CREATED COMPLEX GEOMETRY AND RESULTED IN THE BILUMEN TWISTING UP AND ULTIMATELY CAUSING THE EXTRACTION HELIX TO FRACTURE IN THE GUIDE. IT CAN BE SEEN ON ANGIO THAT WHILE THE PHYSICIAN WAS CONTINUING TO ADVANCE THE CATHETER IN THE VESSEL THE PATIENT WAS EXPOSED TO 5 ROTATIONS OF THE EXTRACTION HELIX. CORRECTIVE ACTIONS: CORRECTIVE ACTIONS ARE NOT REQUIRED AT THIS TIME. THE DEVICE PERFORMANCE WITH THE VARIABLE PITCH EXTRACTION HELIX WILL CONTINUE TO BE MONITORED DURING THE POST-MARKET PHASE.

    Description of Event or Problem · 1

    A CORONARY ANEURYSM WAS DIAGNOSED AT THE PROXIMAL PART OF THE SAPHENOUS VEIN BYPASS GRAFT TO THE RAMUS INTERVENTRICULARIS POSTERIOR CORONARY ARTERY. IN A PRIOR INTERVENTION 4 MONTHS EARLIER, THE PATIENT HAD RECEIVED A GRAFTMASTER/JOSTENT (ABBOTT). THE SIZE OF THE ANEURYSM WAS 15 MM LENGTH BY 10 MM WITH THROMBOTIC MATERIAL. IN 2008, THE PATIENT PRESENTED WITH IN-STENT THROMBOSIS IN THE GRAFTMASTER STENT. THE PHYSICIAN PLACED A 7 F MP A1 GUIDING CATHETER. AFTER PLACING AN INTERVENTIONAL GUIDEWIRE IN THE VESSEL, THE USED THROMCAT. THE FIRST RUN WORKED WITHOUT PROBLEMS AND THERE WAS SOME REDUCTION IN THE THROMBUS BURDEN. THE PHYSICIAN THEN DECIDED TO USE THROMCAT FOR A SECOND RUN. DURING THE PULL-BACK, HE FELT RESISTANCE AND IT WAS VERY DIFFICULT TO RETRACT THE THROMCAT CATHETER. AFTER REMOVAL, THE PHYSICIAN NOTICED A 1.3 CM SLIT IN THE CATHETER JACKET APPROXIMATELY 7 CM FROM THE TIP. THERE WAS NO EVIDENCE OF VESSEL INJURY ON ANGIOGRAPHY. THE PHYSICIAN THEN STENTED THE COMPLETE REGION WITH A STENTGRAFT 4.0 X 16 MM AND A 4.0 X 20 MM PROKINETIK BMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THROMCAT THROMBECTOMY CATHETER THROMBECTOMY CATHETER MCW KENSEY NASH CORP. NA 57785

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR INTERVENTIONAL GUIDEWIRE