BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 11996180 · Received June 14, 2021

    Report

    Report Number
    3013394970-2021-00348
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    May 5, 2021
    Report Date
    June 14, 2021
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. ONE 6FR ANGIO-SEAL VIP WAS RETURNED FOR PRODUCT EVALUATION. THE RETURNED SAMPLE INCLUDED THE HEADER BAG, HEMOSTASIS SHEATH, POLYFOIL POUCH AND CARRIER TUBE ASSEMBLY. THE CARRIER TUBE ASSEMBLY WAS MATED TO THE HEMOSTASIS SHEATH AND THE LOCKING MECHANISM WAS SET TO REAR LOCK POSITION. THE RETURNED SAMPLE WAS SUBJECTED TO VISUAL ANALYSIS. THE POLYFOIL POUCH WAS OBSERVED TO NOT HAVE BEEN OPENED FULLY. THE ANCHOR WAS ALSO OBSERVED TO BE INSIDE THE HEMOSTASIS SHEATH. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED DEVICE. THE LOCKING MECHANISM WAS RESET. THE ANCHOR WAS OBSERVED TO BE RELEASED FROM THE HEMOSTASIS SHEATH. THE DEVICE CAP OF THE CARRIER TUBE ASSEMBLY WAS PULLED BACK TO SET THE LOCKING MECHANISM TO REAR LOCK POSITION. THE ANCHOR WAS OBSERVED TO BE POSTED ON THE TIP OF THE HEMOSTASIS SHEATH. THE ANCHOR WAS PULLED, AND THE COLLAGEN, SUTURE AND TAMPER TUBE WERE RELEASED FROM THE HEMOSTASIS SHEATH. NO FUNCTIONAL ANOMALIES WERE OBSERVED. THE COMPLAINT COULD BE CONFIRMED FOR DEVICE PULLOUT. THE EXACT ROOT CAUSE OF THIS FAILURE CANNOT BE DETERMINED. BASED ON THE RETURNED DEVICE, THE LIKELY ROOT CAUSES FOR THIS ISSUE MAY BE THE USER NOT PLACING THE DEVICE IN THE FULL FORWARD LOCK POSITION OR AN OBSTRUCTION TO THE ANCHOR POSTING TO THE DISTAL TIP. THE DHR REVIEW DETERMINED THAT THE DEVICE WAS IN A CONFORMING STATE WHEN RELEASED FROM TERUMO CONTROL. THERE IS NO INDICATION THAT ANY MANUFACTURING ISSUES MAY HAVE LED TO THIS EVENT. CURRENTLY NO ACTION IS RECOMMENDED SINCE THIS RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE FMEA.

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI - UNKNOWN DUE TO UNKNOWN LOT NUMBER. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURE DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A CORONARY ANGIOGRAPHY AT THE HOSPITAL THE OPERATOR EXPERIENCED AN ANGIO-SEAL DEVICE WHERE THE ANCHOR DID NOT DEPLOY AS INTENDED AND THE WHOLE DEVICE CAME OUT. THE OPERATOR REPORTS THAT THE DEVICE SEEMED ]EMPTY WITH NO SUTURE OR ANCHOR VISIBLE. HEMOSTASIS WAS ACHIEVED BY APPLICATION OF MANUAL COMPRESSION. THE PROCEDURE PERFORMED FOR THE PATIENT PRIOR TO USE OF CLOSURE DEVICE WAS A KAG - CORONARY ANGIOGRAPHY. A 6FR PROCEDURAL SHEATH WAS USED. THERE WERE NO DIFFICULTIES AT ALL WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. NO PRE-DEPLOYMENT ANGIOGRAM PERFORMED. THERE WERE NO ISSUES WITH INSERTION, DEPLOYMENT, OR WITHDRAWAL OF THE DEVICE, HOWEVER THE DEVICE SEEMED EMPTY, NO STRING OR GREEN PIN VISIBLE. THE PATIENT WAS IN STABLE CONDITION. HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886341 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 0000032259

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention