BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLOCK¿

    MDR report key: 4960067 · Received August 3, 2015

    Report

    Report Number
    2134265-2015-05039
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 7, 2015
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K060078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. A DISPENSER COIL, RHV , INTRODUCER SHEATH AND PUSHER WIRE WERE RETURNED FOR THIS COMPLAINT. A VISUAL INSPECTION WAS PERFORMED. THE PUSHER WIRE WAS RETURNED OUTSIDE THE INTRODUCER SHEATH. THE INTRODUCER SHEATH WAS INSPECTED AND NO ANOMALY WAS NOTED. THE TWIST LOCK ON THE INTRODUCER SHEATH HAD BEEN OPENED. THE RHV WAS INSPECTED AND NO ANOMALY WAS NOTED. THE RHV THUMBSCREW HAD BEEN OPENED. THE PUSHER WIRE WAS INSPECTED AND FOUND TO BE SLIGHTLY KINKED AT THE DISTAL END. A MICROSCOPIC INSPECTION WAS PERFORMED. THE INTERLOCKING ARM OF THE PUSHER WIRE WAS INSPECTED AND TRACES OF DRIED BLOOD WAS PRESENT, HOWEVER THE AMOUNT OF DRIED BLOOD PRESENT IS INSUFFICIENT TO DETERMINE IF INSUFFICIENT FLUSH WAS MAINTAINED DURING THE PROCEDURE. 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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COIL WAS MISSING. A 2/6MM X 8CM INTERLOCK COIL WAS LOADED INTO THE MICRO CATHETER, HOWEVER THE PHYSICIAN NOTICED THAT THERE WAS NO COIL ATTACHED TO THE DELIVERY WIRE. THE PATIENT UNDERGONE FLUOROSCOPIC PROCEDURE BUT THE PHYSICIAN COULDN'T LOCATE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME COIL AND MICRO CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT' STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COIL WAS MISSING. A 2/6MM X 8CM INTERLOCK¿ COIL WAS LOADED INTO THE MICRO CATHETER, HOWEVER THE PHYSICIAN NOTICED THAT THERE WAS NO COIL ATTACHED TO THE DELIVERY WIRE. THE PATIENT UNDERGONE FLUOROSCOPIC PROCEDURE BUT THE PHYSICIAN COULDN'T LOCATE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME COIL AND MICRO CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT' STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504010 INTERLOCK¿ DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001361770 16189946

    Patients

    Seq Age Sex Outcome Treatment
    1