BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBERED IDC OCCLUSION SYSTEM

    MDR report key: 2033691 · Received March 30, 2011

    Report

    Report Number
    2134265-2011-01136
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    December 15, 2010
    Report Date
    March 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE INTRODUCER SHEATH AND PUSHER WIRE WERE RETURNED FOR EVALUATION. VISUAL AND MICROSCOPIC ANALYSIS REVEALED THE PUSHER WIRE WAS RETURNED INSIDE THE INTRODUCER SHEATH AND WAS STRETCHED. THE TWIST LOCK WAS NOT FULLY OPENED AND IT WAS NOT POSSIBLE TO ADVANCE OR RETRACT THE PUSHER WIRE. THE INTRODUCER SHEATH WAS INSPECTED AND NO ANOMALY WAS NOTED. THE TWIST LOCK WAS FULLY OPENED AND THE PUSHER WIRE WAS ADVANCED. UPON INSPECTION IT WAS SEEN THE PUSHER WIRE WAS SEVERELY STRETCHED ALONG THE SS COIL LENGTH. THE CORE WIRE WAS BROKEN BETWEEN THE DISTAL SOLDER JOINT AND MID SOLDER JOINT. THE INTERLOCKING ARM OF THE SS COIL WAS INSPECTED AND NO DAMAGE NOTED. THE DIMENSIONS THAT COULD BE PERFORMED WERE FOUND TO BE WITHIN SPECIFICATION. DUE TO THE SEVERE STRETCH ALONG THE DISTAL SECTION OF THE PUSHER WIRE THE CORE WIRE LENGTH AND SS COIL LENGTH COULD NOT BE TAKEN. THE INVESTIGATION PERFORMED DETERMINED THE TWISTLOCK HAD NOT BEEN FULLY OPEN WHICH WOULD HAVE RESULTED IN THE DIFFICULTY INSERTING. MICROSCOPIC INVESTIGATION REVEALED THE TWISTLOCK LOOKED CONSISTENTLY TAUT SIMILAR TO A TWIST LOCK WHICH HAD NEVER BEEN OPENED. THE MOST PROBABLE ROOT CAUSE WAS DETERMINED TO BE USER RELATED AS THE AS THE TWISTLOCK WAS NOT FULLY OPENED. DFU STATES "RELEASE THE INTERLOCK FIBERED IDC OCCLUSION SYSTEM INSIDE ITS INTRODUCER SHEATH BY GENTLY PINCHING THE SHEATH ON BOTH SIDES OF THE TWIST LOCK MECHANISM AND ROTATING PROXIMAL SIDE COUNTER CLOCKWISE 3 ROTATIONS." (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A EMBOLIZATION TREATMENT PROCEDURE, COIL RESISTANCE WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN INTERNAL ILIAC ARTERY. SEVEN UNSPECIFIED COILS WERE DEPLOYED AT THE TARGET LOCATION. A 3MM X 12CM FIBERED IDC SYSTEM ENCOUNTERED RESISTANCE DURING ADVANCEMENT. THE COIL WAS FLUSHED MULTIPLE TIMES HOWEVER THE DEVICE COULD NOT BE INSERTED INTO THE NON BSC MICROCATHETER. THE COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON BSC COIL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. RETURNED PRODUCT ANALYSIS REVEALED A BROKEN CORE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBERED IDC OCCLUSION SYSTEM DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001361510 0013589920

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER, J&J TRANJIT2| GUIDEWIRE: TERUMO GT16 90DEGREE