BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARRICADE COIL

    MDR report key: 6862158 · Received September 13, 2017

    Report

    Report Number
    3009698517-2017-00001
    Event Type
    Malfunction
    Date Received
    September 13, 2017
    Date of Event
    October 25, 2016
    Report Date
    August 10, 2017
    Manufacturer
    BLOCKADE MEDICAL
    Product Code
    HCG
    PMA / PMN Number
    K151760
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY IMPLANTED AND THE PUSHER WAS NOT RETURNED FOR INVESTIGATION. WITHOUT THE DEVICE, A PRODUCT INVESTIGATION WAS NOT POSSIBLE. BASED ON THE COMPLAINT DESCRIPTION ALONE, THE DEFINITIVE ROOT CAUSE OF THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016 WHILE TREATMENT WITH BARRICADE COILS, THE COIL PREMATURELY DETACHED AND STRETCHED. ON 08/22/2017 LETTER RECEIVED FROM (B)(6), WITH ADDITIONAL INFORMATION. EVENT DATE: (B)(6) 2016, LOT NUMBER: 021216A-080, PART NUMBER: 900080. EVENT DESCRIPTION: DURING DEPLOYMENT OF THE LAST COIL THE BARRICADE COMPLEX FRAME 11MM X 37CM OF THE COIL WAS ONLY PARTIALLY DEPLOYED WITHIN THE CAVERNOUS SINUS AND SPONTANEOUSLY DETACHED FROM THE POSTERIOR WIRE DUE TO A LIKELY DEVICE MALFUNCTION. WE THEN UNSUCCESSFULLY ATTEMPTED TO PUSH THE REMAINING LOOSE COIL INTO THE CAVERNOUS SINUS WITH THE ECHELON 10. WE THEN ATTEMPTED TO FLUSH THE COIL OUT OF THE MICROCATHETER WHERE IT ENDED UP LODGED AT THE LEFT INTERNAL JUGULAR VEIN. THE COIL SUBSEQUENTLY FELL INTO THE INTERNAL JUGULAR VEIN DOWN INTO THE INNOMINATE VEIN INTO THE SUPERIOR VENA CAVA AT THE SVC RIGHT ATRIUM JUNCTION. ON 8/29/2017 ADDITIONAL INFORMATION RECEIVED; (B)(4) (BLOCKADE MEDICAL SALES REPRESENTATIVE) SPOKE TO DR. (B)(6) (TREATING PHYSICIAN) VIA PHONE CALL. DR. (B)(6) CONFIRMED THE EVENT FROM FDA LETTER. ADDING THE FOLLOWING: PATIENT WAS INVOLVED IN A CAR ACCIDENT. PATIENT WAS TREATED WITH BLOCKADE COILS. DEVICE MALFUNCTION AND WAS LODGED INTO THE PATIENTS LEFT INTERNAL JUGULAR VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642528 BARRICADE COIL BARRICADE COIL HCG BLOCKADE MEDICAL 9000801137FR18 021216A-080

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization