BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRICADE

    MDR report key: 7744112 · Received August 2, 2018

    Report

    Report Number
    3009698517-2018-00009
    Event Type
    Injury
    Date Received
    August 2, 2018
    Date of Event
    July 2, 2018
    Report Date
    August 16, 2018
    Manufacturer
    BALT USA, LLC
    Product Code
    HCG
    UDI-DI
    00818053021220
    PMA / PMN Number
    K151760
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BARRICADE COIL WAS NOT RECEIVED FOR EVALUATION, AS IT WAS IMPLANTED. THEREFORE; AND ANALYSIS COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFORMATION THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    THE BARRICADE COIL WAS NOT RECEIVED FOR EVALUATION, AS IT WAS IMPLANTED. THEREFORE, AN ANALYSIS COULD NOT BE PREFORMED. BASED ON THE PROVIDED INFORMATION, ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED. 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 A "COIL WAS PREPARED AS PER THE IFU AND PUSHED INSIDE MICRO CATHETER. BARRICADE COMPLEX FINISH 5X8 COIL WAS DEPLOYED IN ATOM ANEURYSM. AFTER COMPLETE COIL DEPLOYMENT PHYSICIAN WAITED FOR 10 MINUTES TO TAKE CHECK SHOOT BEFORE DETACHMENT. IN CHECK SHOOT IT WAS OBSERVED THAT OPPOSITE A2 WAS NOT FILLING SO PHYSICIAN DECIDED TO RETRIEVE THE COIL. WHILE RETRIEVING COIL IT GOT PREMATURELY DETACHED INSIDE MICRO CATHETER. COIL WAS LEFT LIKE THAT & CASE WAS ABANDONED SINCE 70% OF COIL REMAINED INSIDE ANEURYSM & 30% IN VESSEL. PATIENT KEPT ON VENTILATOR POST CASE".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A "COIL WAS PREPARED AS PER THE IFU AND PUSHED INSIDE MICRO CATHETER. BARRICADE COMPLEX FINISH 5X8 COIL WAS DEPLOYED IN ATOM ANEURYSM. AFTER COMPLETE COIL DEPLOYMENT PHYSICIAN WAITED FOR 10 MINUTES TO TAKE CHECK SHOOT BEFORE DETACHMENT. IN CHECK SHOOT IT WAS OBSERVED THAT OPPOSITE A2 WAS NOT FILLING SO PHYSICIAN DECIDED TO RETRIEVE THE COIL. WHILE RETRIEVING COIL IT GOT PREMATURELY DETACHED INSIDE MICRO CATHETER. COIL WAS LEFT LIKE THAT & CASE WAS ABANDONED SINCE 70% OF COIL REMAINED INSIDE ANEURYSM & 30% IN VESSEL. PATIENT KEPT ON VENTILATOR POST CASE. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583583 BARRICADE BARRICADE COIL HCG BALT USA, LLC 900123 120315A 00818053021220

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R