BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRUS MICROCOIL SYSTEM

    MDR report key: 2475196 · Received February 29, 2012

    Report

    Report Number
    2954740-2012-00015
    Event Type
    Injury
    Date Received
    February 29, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 6, 2012
    Manufacturer
    MICRUS ENDOVASCULAR CORPORATION
    Product Code
    MJN
    PMA / PMN Number
    K091504
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REPORTED: (B)(4); LOT# G14972; MFG DATE; 09/2011; EXPIRATION DATE: 09/30/2016. PRODUCT ANALYSIS: DEVICE 1 (B)(4): THE COIL WAS RETURNED UNDAMAGED AND STILL ATTACHED TO THE DEVICE POSITIONING UNIT (DPU). THE COIL WAS REPORTED AS PROTRUDING OUT OF THE ANEURYSM AND WAS SNARED. HOWEVER IT CANNOT BE EXPLAINED HOW THE COIL WAS RETURNED STILL FULLY ATTACHED TO THE DPU. THE DETACHMENT FIBER DID NOT RECEIVE HEAT AND MELT. THE DPU PASSED ELECTRICAL TESTING. THE COIL WAS DETACHED ON THE FIRST DETACHMENT ATTEMPT. LAB TESTING COULD NOT DUPLICATE THE FIELD COMPLAINT. DEVICE 2 (B)(4): THE DAMAGED COIL WAS RETURNED SEVERED OUT OF THE SOLDERED SECTION WHICH REQUIRED EXCESSIVE FORCE. THE PROXIMAL END OF THE COIL WAS STILL FULLY ATTACHED TO THE DEVICE POSITIONING UNIT (DPU). THE DPU PASSED ELECTRICAL TESTING. THE PROXIMAL END OF THE COIL DETACHED ON THE FIRST DETACHMENT ATTEMPT. THE DETACHMENT FIBER RECEIVED HEAT AND MELTED AS DESIGNED. LAB TESTING COULD NOT DUPLICATE THE FIELD COMPLAINT. THE EVIDENCE DOES SUGGEST THAT THE KNOTTED COIL AT THE DISTAL TIP OF THE COIL MAY HAVE PULLED THE COIL MASS AND/OR THE OTHER COIL THAT PROLAPSED OUT OF THE ANEURYSM DURING REPOSITIONING. HOWEVER, THE OTHER COIL CONTAINED IN THIS COMPLAINT WAS STILL FULLY ATTACHED TO THE DPU WHICH CANNOT BE EXPLAINED. THE EXACT CIRCUMSTANCES OF HOW THIS EVENT OCCURRED CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE RETURN OF THE COMPLETE DETACHMENT SYSTEM AND THE PROWLER 14 MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT.

    Description of Event or Problem · 1

    PER RECEIVED REPORT: AS THE TWO (2) COILS WERE PLACED AND DETACHMENT WAS ATTEMPTED, IT WAS NOTICED THAT THE COIL DIDN'T PROPERLY DETACH AND WERE PROLAPSING OUT OF THE ANEURYSM INTO THE PT ARTERY WITH THE DEVICE POSITIONING UNIT (DPU) AND PORTION OF THE COIL STILL IN THE MICROCATHETER. AT THAT POINT, SNARE WAS USED TO SECURE THE COIL MASS ALONG WITH THE MICROCATHETER AND BOTH COILS WERE RETRIEVED FROM THE PT WITHOUT ANY ISSUE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRUS MICROCOIL SYSTEM EMBOLIC COIL MJN MICRUS ENDOVASCULAR CORPORATION G13895

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention