BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE,OUS

    MDR report key: 17140793 · Received June 15, 2023

    Report

    Report Number
    3013394970-2023-00237
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 5, 2023
    Report Date
    June 15, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE CORRECTED INFORMATION TO SECTIONS B5 AND E1. IN THE INITIAL REPORT THE INFORMATION IN BOTH OF THOSE SECTIONS WERE INCORRECT BECAUSE THE INITIAL REPORTER HAD PROVIDED THE INCORRECT INFORMATION TO TERUMO WHICH WAS THEN INTIALLY REPORTED INCORRECTLY ON THE 3500A FORM. BASED ON THE CORRECTED INFORMATION RECEIVED IT HAS BEEN DETERMINED THAT THIS REPORT SHOULD BE CONSIDERED NOT REPORTABLE.

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT AVAILABLE DUE TO PRIVACY. A2: AGE & DATE OF BIRTH: REQUESTED, NOT AVAILABLE DUE TO PRIVACY. A3: PATIENT SEX: REQUESTED, NOT AVAILABLE DUE TO PRIVACY. A4: WEIGHT: REQUESTED, NOT AVAILABLE DUE TO PRIVACY. A5: ETHNICITY: REQUESTED, NOT AVAILABLE DUE TO PRIVACY. A6: RACE: REQUESTED, NOT AVAILABLE DUE TO PRIVACY. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 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.

    Description of Event or Problem · 0

    CORRECTED DESCRIPTION WAS RECEIVED ON 12 JUN 2023: THE SHEATH AND DILATOR COULD NOT MOVE THROUGH THE SKIN LEVEL JUST BEFORE ENTERING THE ARTERY. THE SAME HAPPENED WITH THE SECOND ANGIO-SEAL (SHEATH AND DILATOR). THE PHYSICIAN DECIDED TO TAKE ANOTHER ANGIO-SEAL WITH A DIFFERENT LOT-NUMBER AND COULD EASY MOVE THE SHEATH AND DILATOR OVER THE WIRE AND THROUGH THE SKIN LEVEL INTO THE ARTERY AND TREATED THE PATIENT AS PLANNED. THE PATIENT WAS TREATED AS INTENDED. THERE WAS NO SIGNIFICANT DELAY OF THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE INCIDENT HAPPENED DURING THE STEP "SET THE ANCHOR" AFTER THE TRANS ARTERIAL CHEMOEMBOLIZATION (TACE) INTERVENTION WITH A 6F IK DEVICE. THE PHYSICIAN INSERTED THE ANGIO-SEAL INTO THE SHEATH, FIRST CLICK AND SECOND CLICK TO SET THE ANCHOR. DURING THIS PROCEDURE HE WAS NOT ABLE TO PULL BACK THE ANGIO-SEAL OVER THE TWO FINAL CLICKS. HE GRABBED THE SUTURE MANUALLY AND WAS ABLE TO PULL BACK THE DEVICE UNTIL THE SUTURE STOPPED. HE PUSHED DOWN THE TUBE UNTIL REACHING THE BLACK MARKER, CONFIRMED THE HEMOSTASIS AND CUT THE SUTURE. THERE WAS NO BLEEDING OR HEMATOMA AFTER THE INTERVENTION MENTIONED. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 05 JUN 2023: THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2228875 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE,OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 0000291321

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown