BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 9752082 · Received February 25, 2020

    Report

    Report Number
    3013394970-2020-00070
    Event Type
    Malfunction
    Date Received
    February 25, 2020
    Date of Event
    January 23, 2020
    Report Date
    February 25, 2020
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER - REQUESTED, NOT PROVIDED. AGE & DATE OF BIRTH - REQUESTED, NOT PROVIDED. SEX - REQUESTED, NOT PROVIDED. WEIGHT - REQUESTED, NOT PROVIDED. ETHNICITY - REQUESTED, NOT PROVIDED. RACE - REQUESTED, NOT PROVIDED. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. ONE 8FR ANGIO-SEAL STS PLUS WAS RECEIVED FOR PRODUCT EVALUATION. THE CARRIER TUBE ASSEMBLY AND BYPASS TUBE WERE RETURNED. NO POLY FOIL POUCH WAS RETURNED. VISUAL INSPECTION REVEALED THAT THE BYPASS TUBE WAS COMPLETELY DETACHED FROM THE MAIN BODY OF THE CARRIER TUBE AND THE ANCHOR AND SWOLLEN COLLAGEN WERE EXPOSED AS CAN BE SEEN IN THE PICTURES. THE TIP OF THE CARRIER TUBE WAS CHECKED, AND NO ANOMALIES WERE NOTED. NO DEFORMATION OR DAMAGE WAS NOTED ON THE ANCHOR AND BYPASS TUBE. NO OTHER VISUAL ANOMALIES WERE NOTED WITH THE DEVICE. FUNCTIONAL TESTING COULD NOT BE PERFORMED; THE BYPASS TUBE COULD NOT BE REINSERTED OVER THE CARRIER TUBE ASSEMBLY BECAUSE COLLAGEN HAD EXPANDED AS IT WAS LIKELY EXPOSED TO MOISTURE. FOR DIMENSIONAL TESTING, THE INNER DIAMETER OF THE BYPASS TUBE AT THE DISTAL END WAS MEASURED AND FOUND TO BE 0.110" AND WHICH WAS WITHIN THE SPECIFICATION OF 0.109" +0.002/-0.003. ALL MEASUREMENTS WERE WITHIN THE MANUFACTURER SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE WHEN UNPACKING THE ANGIO-SEAL DEVICE, THE ASSISTANT IN THE HKL NOTICED THAT THE INSERTION OF THE ANGIO-SEAL SYSTEM WAS MISSING, AND THE TIP OF THE SYSTEM WAS CRUSHED. THE ANCHOR DANGLED FREELY IN THE PACKAGING. THE SYSTEM COULD NOT BE USED AND WAS REPLACED BY A NEW ONE. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED ON 03FEB2020. THE SUBJECT COMPONENT WAS THE CARRIER TUBE ASSEMBLY, WHICH WOULD HAVE BEEN UNPACKED FROM THE FOIL POUCH; WHICH HOUSES THE ANCHOR, COLLAGEN AND BYPASS TUBE AT THE TIP. THE PATIENT WAS IN THE PROCEDURE ROOM, AND THE PACKAGE WAS BEING UNPACKED FOR THE CASE IN PROGRESS. HKL MEANS CATH LAB IN (B)(6); HERZKATHETERLABOR. ADDITIONAL INFORMATION WAS RECEIVED ON 05FEB2020. THE ANCHOR WAS ATTACHED TO THE THREAD; HOWEVER, WAS WITHOUT PROTECTION OF THE SMALL INSERTION AID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211940 8F ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 06091481

    Patients

    Seq Age Sex Outcome Treatment
    1