BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THROMCAT THROMBECTOMY CATHETER

    MDR report key: 1001084 · Received February 22, 2008

    Report

    Report Number
    2530154-2007-00013
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    June 1, 2007
    Report Date
    February 21, 2008
    Manufacturer
    KENSEY NASH CORPORATION
    Product Code
    MCX
    PMA / PMN Number
    K060016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIPTION FOR METHOD: SINCE THE DEVICE WAS NOT RETURNED, REVIEW OF THE DEVICE HISTORY FILE AND THE ANGIOGRAM FROM THE PROCEDURE WERE CONDUCTED. AFTER THE PROCEDURE, REP (DISTRIBUTOR IN ANOTHER COUNTRY) INSPECTED AND TESTED THE THROMCAT. THERE WERE NO VISIBLE DEFECTS AND IT OPERATED AS NORMAL IN A BOWL OF SALINE. THE DEVICE HOWEVER, WAS DISCARDED AND IS NOT AVAILABLE FOR ANALYSIS AT KNC. A COPY OF ANGIOGRAPHIC IMAGES OF THE CASE WAS SENT TO KNC FOR EVALUATION. ANGIOGRAPHIC IMAGES FROM THE CASE WERE USED TO ANALYZE AND ESTIMATE THE GEOMETRIES. AN IMAGE (REFERENCE FIGURE 3.0) WAS TAKEN DURING THE THROMCAT RUN (JUST PRIOR TO THE PERFORATION AND THE VESSEL SPASM) TO ASSESS THE VESSEL INSIDE DIAMETER (I.D.) IF THE VESSEL. THE VESSEL I.D. AT THE APPROXIMATE SITE OF THE PERFORATION IS ESTIMATED TO BE 0.112". THIS COINCIDES WITH THE PHYSICIAN'S ASSESSMENT OF 3.0 MM'S. ANOTHER IMAGE (FIGURE 4.0) WAS TAKEN AFTER THE THROMCAT WAS REMOVED FROM THE VESSEL (RETRACTED INTO THE GUIDE) AND CONTRAST MEDIUM WAS INJECTED TO ASSESS THE THROMBUS REMOVAL. AT THIS TIME THE PHYSICIAN NOTICED THAT THE VESSEL HAS BEEN PERFORATED. THE VESSEL I.D. AT THE APPROXIMATE SITE OF THE PERFORATION IS ESTIMATED TO BE 0.058", THIS SUGGESTS THAT THE VESSEL WAS SPASMING AND REDUCED THE VESSEL I.D. ROOT CAUSE: THE CAUSE OF THE VESSEL PERFORATION IS UNKNOWN. THERE WERE NO NOTICEABLE DEFECTS ON THE THROMCAT DEVICE, WHICH WOULD HAVE CONTRIBUTED TO THE VESSEL PERFORATION. IT CAN BE SPECULATED THAT THE ENTIRE LENGTH OF THE VESSEL WALL WAS WEAK AND MORE PRONE TO INJURY. THIS IS EVIDENT DUE TO THE ANEURYSM IN THE CULPRIT LESION, WHICH IS CAUSED BY DISEASE OR WEAKENING OF THE VESSEL WALL. CORRECTIVE ACTION: ACTION IS NOT REQUIRED AT THIS TIME. THROMCAT DEVICE WAS USED UNDER PHYSICIAN'S DISCRETION.

    Description of Event or Problem · 1

    THE PATIENT WAS A OBESE MALE WHO WAS INTUBATED WHEN BROUGHT TO THE CATH-LAB. INITIAL ANGIOGRAPHY OF THE RCA REVEALED A TOTALLY OCCLUDED VESSEL PROXIMALLY. A GUIDEWIRE WAS ADVANCED THROUGH THE OCCLUSION AND INTO A DISTAL BRANCH OF RCA. THROMCAT WAS THEN ACTIVATED AND ADVANCED THROUGH THE FIRST HALF OF THE RCA. ANGIOGRAPHY THEN SHOWED A PATENT VESSEL WITH TIMI 2 FLOW. IN THE PROXIMAL VESSEL A LARGE ANEURYSM WITH RESIDUAL CLOT COULD BE APPRECIATED. JUST BEYOND THE ANEURYSM WAS A HIGH-GRADE STENOSIS. ALSO, IT APPEARED THAT SOME CLOT HAD MOVED TO THE DISTAL PART OF THE RCA. THE PHYSICIAN DECIDED TO PERFORM A SECOND RUN OF THROMCAT. AFTER THE RUN, ANGIOGRAPHY REVEALED FURTHER REDUCTION OF THE CLOT IN THE ANEURYSM AND COMPLETE REMOVAL OF THE DISTAL CLOT. HOWEVER, THERE WAS EXTRAVASATION OF CONTRAST IN THE RCA AND VESSEL SPASM. THE PHYSICIAN PERFORMED TRANSTHORACIC ULTRASOUND AND RULED OUT PERICARDIAL EFFUSION AND TAMPONADE. HE THEN PERFORMED IVUS IN THE RCA, WHICH CONFIRMED A SMALL TEAR IN THE VESSEL WALL SURROUNDED BY A LARGE HEMATOMA. TWO BARE METAL STENTS WERE PLACED IN THE AREA OF THE SPASM AND THE TEAR, WHICH RESOLVED BOTH ISSUES. THEN, TWO COVERED STENTS WERE DEPLOYED IN THE PROXIMAL VESSEL TO EXCLUDE THE ANEURYSM AND OPEN THE CULPRIT LESION. FINAL ANGIOGRAPHY REVEALED TIMI 2 TO 3 FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THROMCAT THROMBECTOMY CATHETER THROMBECTOMY CATHETER MCX KENSEY NASH CORPORATION NA 54050

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening INTERVENTIONAL GUIDEWIRE