BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 17892734 · Received October 8, 2023

    Report

    Report Number
    3013394970-2023-00543
    Event Type
    Injury
    Date Received
    October 8, 2023
    Date of Event
    April 19, 2022
    Report Date
    October 8, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: UNKNOWN. A2: AGE & DATE OF BIRTH: UNKNOWN. A3: PATIENT SEX: UNKNOWN. A4: WEIGHT: UNKNOWN. A5: ETHNICITY: UNKNOWN. A6: RACE: UNKNOWN. D4: LOT NUMBER: UNKNOWN. D4: EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. D4: UDI: UNKNOWN DUE TO UNKNOWN LOT NUMBER. D6B: EXPLANTED DATE: UNKNOWN IF THE DEVICE WAS EXPLANTED. E1: STREET ADDRESS: UNKNOWN. E1: TELEPHONE NUMBER: UNKNOWN. E3: OCCUPATION: VASCULAR SURGEON. H4: DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE COMPLAINT WAS CONFIRMED FOR A POTENTIAL CLOSURE COMPLICATION RESULTING IN A HEMATOMA AND REVISION SURGERY. THE EXACT ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE LIKELY CAUSE WAS DETERMINED TO HAVE BEEN PROCEDURAL TECHNIQUE OR PROCEDURAL FACTORS CONTRIBUTING TO THE REPORTED ADVERSE EVENT. THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE REVIEWED AS A VALID LOT NUMBER WAS NOT IDENTIFIED. THERE IS NO INDICATION THAT ANY MANUFACTURING, DESIGN, OR QUALITY SYSTEM ISSUES MAY HAVE LED TO THIS EVENT. CURRENTLY, NO ACTION IS RECOMMENDED SINCE THIS RISK EVALUATION IS WITHIN THE PREDETERMINED LIMITS IN THE FAILURE MODE AND EFFECTS ANALYSIS (FMEA). THIS REPORT IS FOR THE SECOND DEVICE/PATIENT REPORTED, FOR THE FIRST DEVICE/PATIENT REPORTED THAT HAD DEVELOPED A HEMATOMA SEE MDR 3013394970-2023-00542.

    Description of Event or Problem · 0

    FROM LITERATURE REVIEW: ZENUNAJ, G, TRAINA, L, ACCIARRI, P, MUCIGNAT, M, SCIAN, S, ALESIANI, F, SERRA, R, GASBARRO, V. SUPERFICIAL FEMORAL ARTERY ACCESS FOR INFRAINGUINAL ANTEGRADE ENDOVASCULAR INTERVENTIONS IN THE HOSTILE GROIN: A PROSPECTIVE RANDOMIZED STUDY. ANNALS OF VASCULAR SURGERY. 2022. 86: #PAGES#. A PROSPECTIVE OBSERVATIONAL RANDOMIZED STUDY EXAMINED PATIENTS WITH SYMPTOMATIC PERIPHERAL ARTERIAL DISEASE WHO REQUIRED ENDOVASCULAR INTERVENTIONS AT THE LOWER EXTREMITIES. THE STUDY COMPARED A CUTDOWN APPROACH TO THE PERCUTANEOUS PUNCTURE TECHNIQUE. A 6FR ANGIO-SEAL VIP WAS USED TO ACHIEVE HEMOSTASIS IN THE PERCUTANEOUS PUNCTURE TECHNIQUE. TWO OF THE PATIENTS HAD PROCEDURAL HEMATOMAS. THIS COMPLAINT IS BEING OPENED FOR THE HEMATOMA THAT DID NOT REQUIRE SURGICAL REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2156948 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other