BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, US

    MDR report key: 7095031 · Received December 7, 2017

    Report

    Report Number
    2243441-2017-00218
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    November 9, 2017
    Report Date
    December 7, 2017
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER - (B)(6). THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER - REQUESTED BUT NOT PROVIDED. DATE OF BIRTH - REQUESTED BUT NOT PROVIDED. WEIGHT - (B)(6) KG. ETHNICITY - REQUESTED, INFORMATION NOT RECEIVED. RACE - REQUESTED, INFORMATION NOT RECEIVED. EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI - UNKNOWN DUE TO UNKNOWN LOT NUMBER. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. DEVICE MANUFACTURE DATE - UNKNOWN DUD TO UNKNOWN LOT NUMBER. THE ACTUAL DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE EVALUATION OF THE ACTUAL DEVICE COULD NOT BE CONDUCTED DUE TO THE DEVICE NOT BEING RETURNED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 12/18/2017: IT WAS REPORTED THAT THERE WAS NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED, JUST OBSERVATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE 8 FR ANGIO-SEAL EVOLUTION WAS SUCCESSFULLY DEPLOYED AND HEMOSTASIS ACHIEVED IN LEFT COMMON FEMORAL ARTERY FOLLOWING EMBOLECTOMY FOR STROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: FELLOW REACHED OUT THE FOLLOWING DAY TO ASK IF ANGIO-SEAL COULD HAVE CAUSED A DISSECTION OF THE PROFUNDA ARTERY. PUNCTURE WAS ABOVE BIFURCATION OF THE COMMON FEMORAL ARTERY, BELOW THE IEG ARTERY AND IN A HEALTHY SEGMENT OF THE CFA AND THEREFORE SHOULD NOT HAVE INVOLVED THE PROFUNDA. HE SAID THAT HE THOUGHT ACCESS WAS PROBABLY TO BLAME RATHER THAN THE ANGIO-SEAL DEVICE. PER THE PHYSICIAN, "SHE HAD A HEMOGLOBIN DROP SO THEY DID A CTA OF HER ABDOMEN AND PELVIS AND THAT'S HOW THEY FOUND IT (THE DISSECTION). LOOKING BACK THROUGH THE RECORDS SHE HAD A SLOW HEMOGLOBIN DROP SINCE ADMISSION." IT WAS REPORTED THAT THE PATIENT WAS STABLE. IT WAS REPORTED THAT THE PROCEDURE OUTCOME WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875526 8F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, US DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR