BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCKING DETACHABLE COIL

    MDR report key: 2222073 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03459
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED DEVICE REVEALED THE COIL WAS PROTRUDING FROM THE TIP OF A NON BSC CATHETER. DUE TO A LARGE QUANTITY OF DRIED BLOOD PRESENT IN THE INTRODUCER SHEATH, RHV AND CATHETER, THE DELIVERY WIRE AND COIL COULD NOT BE ADVANCED. THE DELIVERY WIRE WAS RETRACTED THROUGH THE CATHETER AND SHEATH AND FOUND TO BE KINKED. NO ANOMALIES WERE OBSERVED WITH THE INTRODUCER SHEATH. MICROSCOPIC INSPECTION OF THE INTERLOCKING ARM OF THE DELIVERY WIRE REVEALED NO DAMAGE. THE ZAP TIP SHAPE AND SURFACE OF BOTH THE DELIVERY WIRE AND THE COIL WERE SMOOTH. DIMENSIONAL MEASUREMENTS WHICH WERE ABLE TO BE TAKEN OF THE DELIVERY WIRE AND COIL WERE FOUND TO BE IN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED AS CONTINUOUS FLUSH WAS NOT MAINTAINED AND AN INCORRECT CATHETER WAS USED PER THE DFU. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(4) 2011. IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, ADVANCEMENT DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS HYPOGASTRIC ARTERY. UTILIZING INTERMITTENT FLUSH, TWO 10X40 INTERLOCKING DETACHABLE COILS (IDC) WERE SUCCESSFULLY DEPLOYED VIA A 5FR NON BSC CATHETER. THE NEXT TWO COILS, BOTH .035 20MMX40CM IDCS, COULD NOT BE ADVANCED AS RESISTANCE WAS NOTED IN THE HUB OF THE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 10X40 IDC. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A 20MMX40CM IDC PROTRUDING FROM THE CATHETER'S DISTAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLOCKING DETACHABLE COIL DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK M001363830 14347840

    Patients

    Seq Age Sex Outcome Treatment
    1 5FR 65CM COOK KMP CATHETER