BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDC¿

    MDR report key: 2222635 · Received August 25, 2011

    Report

    Report Number
    2134265-2011-03654
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K040342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED PRODUCT REVEALED THE INTRODUCER SHEATH, PUSHER WIRE AND COIL WERE RETURNED. BLOOD WAS PRESENT IN THE INTRODUCER SHEATH. THE COIL WAS NOT ATTACHED TO THE PUSHER WIRE INSIDE THE INTRODUCER SHEATH. THE PUSHER WIRE INTERLOCKING ARM HAD BEEN PULLED OFF AND WAS NOT RETURNED. THE PUSHER WIRE WAS REMOVED FROM THE INTRODUCER SHEATH WITH RESTRICTION DUE TO DRIED BLOOD. THE PUSHER WIRE WAS INSPECTED AND THE DISTAL END WAS FOUND TO BE SEVERELY STRETCHED. THE COIL WAS INSPECTED AND A SLIGHT STRETCH WAS NOTED AT THE DISTAL END. MICROSCOPIC INSPECTION OBSERVED THE ZAP TIP SHAPE AND SURFACE WERE SMOOTH. THE INTERLOCKING ARM OF THE MAIN COIL WAS INSPECTED AND NO DAMAGE NOTED. DRIED BLOOD WAS ATTACHED TO THE PUSHER WIRE. THE CORE WIRE WAS BROKEN AND THE POINT OF THE BREAK WAS JAGGED AND ROUGH. THE MAIN COIL AND PUSHER WIRE DIMENSIONS THAT COULD BE MEASURED WERE FOUND TO BE IN SPECIFICATION. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, THE COIL WAS BROKEN. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. WHILE UTILIZING CONTINUOUS FLUSH, A 2.0MM X 4.0CM 18 SOFT INTERLOCKING DETACHABLE COIL (IDC) WAS ADVANCED INTO A 150CM NON BSC MICROCATHETER. AT AN UNSPECIFIED TIME, THE PHYSICIAN OPTED TO REMOVE THE COIL AFTER DETERMINING THE COIL WOULD NOT ADEQUATELY FIT THE LESION. THE INTRODUCER OF THE DEVICE WAS UTILIZED DURING REMOVAL OF THE COIL AND RESISTANCE WAS MET IN THE PROXIMAL PORTION OF THE CATHETER. THE PHYSICIAN PULLED ON THE PUSHER WIRE, THE COIL STRETCHED AND ONLY THE PUSHER WIRE WAS REMOVED; THE COIL REMAINED IN THE MICROCATHETER. WHEN THE PUSHER WIRE WAS EXAMINED OUTSIDE OF THE PATIENT IT WAS NOTED THAT THE INTERLOCKING ARM OF THE PUSHER WIRE WAS MISSING. THE CATHETER AND COIL WERE REMOVED TOGETHER AND UPON FLUSHING THE DEVICE OUTSIDE OF THE PATIENT, THE COIL EMERGED, BUT THE INTERLOCKING ARM OF THE PUSHER WIRE DID NOT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMBOLIZATION TREATMENT PROCEDURE, THE COIL WAS BROKEN. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. WHILE UTILIZING CONTINUOUS FLUSH, A 2.0MM X 4.0CM 18 SOFT INTERLOCKING DETACHABLE COIL (IDC) WAS ADVANCED INTO A 150CM NON BSC MICROCATHETER. AT AN UNSPECIFIED TIME, THE PHYSICIAN OPTED TO REMOVE THE COIL AFTER DETERMINING THE COIL WOULD NOT ADEQUATELY FIT THE LESION. THE INTRODUCER OF THE DEVICE WAS UTILIZED DURING REMOVAL OF THE COIL AND RESISTANCE WAS MET IN THE PROXIMAL PORTION OF THE CATHETER. THE PHYSICIAN PULLED ON THE PUSHER WIRE, THE COIL STRETCHED AND ONLY THE PUSHER WIRE WAS REMOVED; THE COIL REMAINED IN THE MICROCATHETER. WHEN THE PUSHER WIRE WAS EXAMINED OUTSIDE OF THE PATIENT IT WAS NOTED THAT THE INTERLOCKING ARM OF THE PUSHER WIRE WAS MISSING. THE CATHETER AND COIL WERE REMOVED TOGETHER AND UPON FLUSHING THE DEVICE OUTSIDE OF THE PATIENT, THE COIL EMERGED, BUT THE INTERLOCKING ARM OF THE PUSHER WIRE DID NOT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDC¿ DEVICE, EMBOLIZATION, VASCULAR KRD BOSTON SCIENTIFIC - CORK M0013612040 13733998

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) 150CM MICRO FERRET CATHETER