BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRICADE COIL

    MDR report key: 7539551 · Received May 23, 2018

    Report

    Report Number
    3009698517-2018-00007
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    April 17, 2018
    Report Date
    May 22, 2018
    Manufacturer
    BALT USA, LLC
    Product Code
    HCG
    UDI-DI
    00818053020124
    PMA / PMN Number
    K151760
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BARRICADE COIL WAS SUCCESSFULLY IMPLANTED; THEREFORE IT WAS NOT RECEIVED FOR EVALUATION. ANALYSIS COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THIS COMPLAINT MAY HAVE BEEN RELATED TO THE INCORRECT SELECTION OF THE COIL SIZE AS WELL AS THE MICROCATHETER BEING INSERTED TOO DEEP INTO THE ANEURYSM. REVIEW OF THE LOT HISTORY RECORDS FOR THE REPORTED LOT DID NOT REVEAL ANY IN-PROCESS OR LOT-SPECIFIC ISSUE THAT COULD ACCOUNT FOR THE OBSERVATION. NO ADDITIONAL COMPLAINTS AGAINST THE REPORTED LOT HAVE BEEN MADE FOR THE SAME ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TREATMENT OF AN ANEURYSM LOCATED AT MCA. "THE TIP OF MC (ECHELON 10) WAS PLACED AT MIDDLE OF THE ANEURYSM AND THE COIL WAS PUSH-OUT FROM THE CATHETER. HOWEVER, THE FIRST LOOP CAME OFF FROM THE ANEURYSM, AND MICROCATHETER KICKED-BACK TO MAIN VESSEL DURING WITHDRAWAL OF THE COIL. THEN, THE SURGEON RE-INSERTED THE MICROCATHETER INTO THE ANEURYSM DEEPER THAN FIRST ATTEMPT AND TRIED TO PUSH-OUT THE COIL INTO THE ANEURYSM. WHEN ABOUT 90% OF THE TOTAL LENGTH WAS PLACED, ONE OF THE LOOP WAS CAME OFF OUT OF THE ANEURYSM AND THEN IT WAS CONFIRMED THAT THE PERFORATION WAS OCCURRED. THE SURGEON PERFORMED REVERSING OF HEPARIN AND INFLATING THE BALLOON FOR THE TREATMENT FOR THE PERFORATION. FOUR MINUTES PASSED, THE SURGEON DEFLATED THE BALLOON AND PERFORMED CONTRASTRADIOGRAPHY, IT WAS CONFIRMED THAT THE BLEEDING WAS STOPPED. FINALLY, THE COIL HAD DETACHED PROPERLY AT REVERSE "T" POSITION. THE PROCEDURE WAS COMPLETED SINCE THERE WAS NO PROBLEM FOR THE PATIENT'S SITUATION (CONSCIOUSNESS, SPEECH, VISUAL FIELD ETC.)" SURGEON'S COMMENTS: HE COMMENTED THAT HE MISTOOK THE SELECTION OF THE COIL SIZE, HE SHOULD NOT HAVE BEEN SELECTED LONG COIL. ALSO, HE COMMENTED THAT THE TIP OF MICROCATHETER MIGHT HAVE INSERTED TOO DEEP INTO THE ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379689 BARRICADE COIL BARRICADE COIL HCG BALT USA, LLC 900068 062217A-068 00818053020124

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention