BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VORTX¿ DIAMOND - 18

    MDR report key: 2831341 · Received November 14, 2012

    Report

    Report Number
    2134265-2012-06962
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    September 3, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K914786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THE COIL WAS FOUND TO BE SEVERELY STRETCHED AT ONE END. THE ZAP TIP HAD BEEN PULLED OFF; HOWEVER, THERE WAS ZAPPING POWDER RESIDUE ON THE RETURNED COIL WHICH SHOWED THE COIL HAD COMPLETED THE ZAPPING PROCESS. TRACES OF DRIED BLOOD WERE PRESENT ON THE COIL FIBER BUNDLES. A MICROSCOPIC INSPECTION OF THE REMAINING ZAP TIP ON THE OPPOSITE END OF THE COIL WAS INSPECTED AND THE ZAP TIPS SHAPE AND SURFACE WERE SMOOTH. AS THE COIL WAS SEVERELY DAMAGED ON ONE SIDE NOT ALL COIL DIMENSIONS COULD BE MEASURED, THE DIMENSIONS THAT COULD BE MEASURED WERE FOUND TO BE WITHIN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS USER/USE ERROR. THE DFU STATES THAT "COILS ARE DESIGNED TO BE DELIVERED UNDER FLUOROSCOPY USING A BOSTON SCIENTIFIC 0.53 MM (0.021 IN) LUMEN ID MICROCATHETER WITH A RADIOPAQUE TIP MARKER" AND "COMPATIBILITY WITH MICROCATHETERS OTHER THAN THE BOSTON SCIENTIFIC 0.53 MM (0.021 IN) LUMEN ID MICROCATHETERS HAS NOT BEEN ESTABLISHED". (B)(4).

    Description of Event or Problem · 1

    RELATED COMPLAINTS: SAME CASE AS MFR. 2134265-2012-05977, 2134265-2012-05976, AND 2134265-2012-05978. REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2012. IT WAS REPORTED THAT FOLLOWING AN EMBOLIZATION TREATMENT PROCEDURE, THE COIL BECAME JAMMED INSIDE THE CATHETER. THE TARGET LESION WAS LOCATED IN THE LIVER. THE ANATOMY WAS MODERATELY TORTUOUS. THERE WERE NO RELEVANT COMORBIDITIES. A TOTAL OF 5 COILS WERE USED FOR THIS EMBOLIZATION PROCEDURE. CONTINUOUS FLUSH WAS MAINTAINED THROUGHOUT THE PROCEDURE. THREE VORTX COILS WERE SUCCESSFULLY DEPLOYED. THE 2ND VORTX COIL PASSED THROUGH NON-BSC 2.4F MICROCATHETER, BUT WAS UNABLE TO DETACH FROM THE TIP OF THE NON-BSC .016" MIRCO WIRE. THIS VORTX DIAMOND - 18 COIL BECAME JAMMED INSIDE THE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE THREE PREVIOUSLY PLACED COILS. POST PROCEDURE THE PATIENT WAS MOVED TO THE WARD. THE PATIENT'S SYMPTOMS WERE REPORTED AS AGGRAVATED AND THE PATIENT PASSED AWAY 10 HOURS POST PROCEDURE. IT WAS NOTED THAT THE PATIENT'S CONDITION WAS NOT GOOD ENOUGH TO "HOLD". THE CAUSE OF DEATH IS UNKNOWN. HOWEVER, THE DEVICE ANALYSIS REVEALED THAT THE COIL WAS SEVERELY STRETCHED AND THE ZAP TIP HAD BEEN PULLED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VORTX¿ DIAMOND - 18 DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M0013822030 15153549

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR