BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TARGET 360 STANDARD 14 MM X 30 CM

    MDR report key: 2983092 · Received February 28, 2013

    Report

    Report Number
    3008853977-2013-00038
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC CORK, LTD
    Product Code
    HCG
    PMA / PMN Number
    K093142
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. CONTROLS ARE IN PLACE IN THE TOP ASSEMBLY MANUFACTURING PROCESS TO ENSURE THE INTEGRITY OF PRODUCT BEFORE SHIPPING. IT WAS REPORTED THAT THE COIL BROKE DURING REPOSITION OF THE DEVICE. THE LABELING STATES: "IF IT IS NECESSARY TO REPOSITION THE TARGET COIL, VERIFY UNDER FLUOROSCOPY THAT THE COIL MOVES WITH A ONE-TO-ONE MOTION. IF THE COIL DOES NOT MOVE WITH A ONE-TO-ONE MOTION OR MOVEMENT IS DIFFICULT, THE COIL MAY HAVE STRETCHED AND COULD POSSIBLY MIGRATE OR BREAK. GENTLY REMOVE BOTH THE COIL AND MICROCATHETER AND REPLACE WITH NEW DEVICES." IT IS PROBABLE THAT PROCEDURAL FACTORS ENCOUNTERED DURING THE USE OF THE DEVICE CONTRIBUTED TO THE COIL BREAKAGE. THEREFORE, IT WAS CONCLUDED THAT PROCEDURAL FACTORS WAS THE MOST LIKELY CAUSE OF THE REPORTED ISSUE AS THE DEVICE PERFORMANCE WAS LIMITED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THE COIL WAS UNEVENTFULLY DELIVERED TO THE TARGET ANEURYSM; HOWEVER, DURING AN ATTEMPT TO REPOSITION THE COIL, THE COIL 'BROKE AND BECAME STRETCHED' IN THE CATHETER. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE COIL 'UNDER SUCTION' AND USING RETRIEVAL DEVICES. A SURGERY WAS PERFORMED; HOWEVER, ATTEMPTS TO REMOVE THE BROKEN COIL RESULTED IN 'TRACTION ON THE CAROTID ARTERY' AND THE BROKEN DEVICE REMAINS INSIDE THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE COIL WAS UNEVENTFULLY DELIVERED TO THE TARGET ANEURYSM; HOWEVER, DURING AN ATTEMPT TO REPOSITION THE COIL, THE COIL "BROKE AND BECAME STRETCHED" IN THE CATHETER. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE COIL "UNDER SUCTION" AND USING RETRIEVAL DEVICES. A SURGERY WAS PERFORMED; HOWEVER, ATTEMPTS TO REMOVE THE BROKEN COIL RESULTED IN "TRACTION ON THE CAROTID ARTERY" AND THE BROKEN DEVICE REMAINS INSIDE THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85843 TARGET 360 STANDARD 14 MM X 30 CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG BOSTON SCIENTIFIC CORK, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention