BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLOCK?

    MDR report key: 3230044 · Received July 16, 2013

    Report

    Report Number
    2134265-2013-04952
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K102912
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED: DEVICE EVALUATED BY MANUFACTURER, EVALUATION SUMMARY ATTACHED. DEVICE EVALUATED BY MANUFACTURER: A COIL AND A PUSHER WIRE WERE RETURNED FOR ANALYSIS. THE COIL WAS INSPECTED AND FOUND TO BE STRETCHED PROXIMALLY INDICATING A RESISTANCE WAS MET DURING THE PROCEDURE. THE COIL WAS ALSO AFTER FOLDING BACK ON ITSELF AND THE FIBER BUNDLES AND THE INTERLOCKING ARM WERE COVERED IN DRIED BLOOD. THE INTERLOCKING ARM OF THE COIL WAS FOUND TO BE SLIGHTLY BENT WHEN THE DRIED BLOOD WAS REMOVED WITH A SWAB. THE PUSHER WIRE WAS FOUND TO BE KINKED PROXIMALLY, DISTALLY AND IN THE SS REGION INDICATING A RESISTANCE WAS MET DURING THE PROCEDURE. THE ZAP TIP SHAPE AND SURFACE WAS SMOOTH. THE INTERLOCKING ARM OF THE COIL WAS INSPECTED AND IT WAS FOUND TO BE SLIGHTLY BENT. THE INTERLOCKING ARM OF THE PUSHER WIRE WAS INSPECTED AND NO DAMAGE NOTED. THE DIMENSIONS THAT COULD BE MEASURED WERE FOUND TO BE IN SPECIFICATION. THE NUMBER OF FIBER BUNDLES RECORDED DURING PRODUCT ANALYSIS WAS BELOW THE ASSIGNED SPECIFICATION. THE REASON FOR THIS IS THE COIL WAS SUBJECTED TO CONDITIONS THAT DAMAGED ITS ORIGINAL STRUCTURE. COIL FIBER BUNDLES ARE RETAINED BY THE TENSION APPLIED BETWEEN COIL LOOPS DURING MANUFACTURE. STRETCHING OF THE COIL MAY POTENTIALLY LEAD TO THE FIBER BUNDLES DETACHING. 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COIL EMBOLIZATION OF A LEFT ARM FISTULA, A STRETCHED AND UNRAVELED COIL OCCURRED. ACCESS WAS OBTAINED VIA LEFT FOREARM. A 3MM X 12 CM FIBERED INTERLOCK DETACHABLE COIL WAS USED TO TREAT THE TARGET VESSEL. DURING PROCEDURE, THE COIL WAS DELIVERED ON THE INTENDED LOCATION. THE PHYSICIAN TRIED TO WITHDRAW THE PUSHER WIRE. HOWEVER, THE PUSHER WIRE CONNECTOR GOT CAUGHT FROM THE COIL. IT WAS THEN NOTED THAT THE COIL GOT STRETCHED AND UNRAVELED ON THE PROXIMAL END. THE COIL WAS COMPLETELY RETRIEVED BY A LOOP SNARE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COIL EMBOLIZATION OF A LEFT ARM FISTULA, A STRETCHED AND UNRAVELED COIL OCCURRED. ACCESS WAS OBTAINED VIA LEFT FOREARM. A 3MM X 12 CM FIBERED INTERLOCK DETACHABLE COIL WAS USED TO TREAT THE TARGET VESSEL. DURING PROCEDURE, THE COIL WAS DELIVERED ON THE INTENDED LOCATION. THE PHYSICIAN TRIED TO WITHDRAW THE PUSHER WIRE. HOWEVER, THE PUSHER WIRE CONNECTOR GOT CAUGHT FROM THE COIL. IT WAS THEN NOTED THAT THE COIL GOT STRETCHED AND UNRAVELED ON THE PROXIMAL END. THE COIL WAS COMPLETELY RETRIEVED BY A LOOP SNARE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328371 INTERLOCK? DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK M001361510 15704644

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention