BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 8649600 · Received May 29, 2019

    Report

    Report Number
    3013394970-2019-00381
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Report Date
    May 29, 2019
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. BASED ON HISTORICAL COMPLAINT DATA FROM COMPLAINTS WHERE EVALUATIONS COULD BE PERFORMED, THE ISSUE MAY BE RELATED TO THE IMPROPER OPENING OF THE POLYFOIL POUCH. PAST COMPLAINT RECORDS HAVE SHOWN THAT IF THE POLYFOIL POUCH IS NOT OPENED COMPLETELY WHEN ATTEMPTING TO REMOVE THE CARRIER TUBE ASSEMBLY, THE BYPASS TUBE CAN BECOME DISLODGED. HOWEVER, WITH NO RETURN OF THE ACTUAL DEVICE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. THE ACTUAL DEVICE WAS NOT RETURNED 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.

    Description of Event or Problem · 1

    ALREADY DETACHED FROM THE CARRIER TUBE TIP. THE DEVICE HAD BEEN STORED ON A LEVEL PLACE. THERE WAS NO OBSTACLE TO OPEN THE POUCH. THE POUCH WAS FULLY OPENED ALL THE WAY FROM THE ARROW SIDE TO THE END. THE BYPASS TUBE WAS LEFT IN THE POUCH. THE DEVICE WAS NOT USED AND ANOTHER ANGIO-SEAL DEVICE WAS USED TO CONTINUE THE PROCEDURE. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED BY THE SECOND DEVICE. THERE WAS NO HEALTH DAMAGE TO THE PATIENT. THE PROCEDURE BEFORE DEPLOYING THE DEVICE WAS A PERCUTANEOUS CORONARY INTERVENTION (PCI). IT IS UNKNOWN IF A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THE SIZE OF THE SHEATH ANCILLARY USED, THE PUNCTURE SITE, AND THE VESSEL DIAMETER ARE UNKNOWN. THERE WAS NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445649 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 06090691

    Patients

    Seq Age Sex Outcome Treatment
    1