BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 17883139 · Received October 5, 2023

    Report

    Report Number
    3013394970-2023-00501
    Event Type
    Injury
    Date Received
    October 5, 2023
    Date of Event
    September 5, 2023
    Report Date
    October 5, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: LITERATURE REVIEW, VCD GROUP. A2: AGE & DATE OF BIRTH: LITERATURE REVIEW VARIABLES, MEAN OF AGE WAS 67.12. A3: PATIENT SEX: LITERATURE REVIEW VARIABLES, MEAN WAS 23 MALES & 11 FEMALES. A4: WEIGHT: LITERATURE REVIEW VARIABLES, MEAN WAS 26.22 FOR BODY MASS INDEX. B3: DATE OF EVENT: LITERATURE REVIEW, BETWEEN JANUARY 2014 AND FEBRUARY 2015. D4: EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN CATALOG AND LOT NUMBER COMBINATION. D4: UDI: UNKNOWN DUE TO UNKNOWN CATALOG AND LOT NUMBER COMBINATION. D6A: IMPLANTED DATE LITERATURE REVIEW, BETWEEN JANUARY 2014 AND FEBRUARY 2015. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. THE PRODUCT CODE/LOT # COMBINATION 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. HOWEVER, THE EXACT ROOT CAUSE WAS UNABLE TO BE DETERMINED. THE LIKELY CAUSE WAS DETERMINED TO HAVE BEEN PROCEDURAL FACTORS OR DEPLOYMENT TECHNIQUE 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 ONE OF THE PATIENTS THAT EXPERIENCED A HEMATOMA GREATER THAN 5CM. PLEASE SEE MDRS 3013394970-2023-00498 TO 3013394970-2023-00500, AND 3013394970-2023-00502 TO 3013394970-2023-00512 FOR THE OTHER PATIENTS THAT EXPERIENCED VASCULAR COMPLICATIONS.

    Description of Event or Problem · 0

    FROM ARTICLE: SU, S.-F., CHANG, M.-Y., WU, M.-S. AND LIAO, Y.-C. (2019), SAFETY AND EFFICACY OF USING VASCULAR CLOSURE DEVICES FOR HEMOSTASIS ON SHEATH REMOVAL AFTER A TRANSFEMORAL ARTERY PERCUTANEOUS CORONARY INTERVENTION. JPN J NURS SCI, 16: 172-183. HTTPS://DOI.ORG/10.1111/JJNS.12221.A STUDY WAS CONDUCTED TO DETERMINE THE EFFICACY OF VASCULAR CLOSURE DEVICES (VCDS) FOR HEMOSTASIS FOLLOWING TRANSFEMORAL PERCUTANEOUS CORONARY INTERVENTIONS (PCIS). A SAMPLING OF THIRTY-FOUR PATIENTS WERE ALLOCATED TO THE EXPERIMENTAL GROUP TO RECEIVE VCDS TO ACHIEVE HEMOSTASIS. A TOTAL OF FIFTEEN OUT OF THE THIRTY-FOUR PATIENTS DEVELOPED POSTOPERATIVE VASCULAR COMPLICATIONS IN THE VCD GROUP. IN THE VCD GROUP, THE MAJOR COMPLICATIONS INCLUDED TWO PATIENTS WITH HEMATOMAS LESS THAN 5CM, FOUR PATIENTS WITH HEMATOMAS GREATER THAN 5CM ALL FIFTEEN PATIENTS HAD BRUISING. NONE OF THE PARTICIPANTS REQUIRED ADDITIONAL SURGERY TO REPAIR PUNCTURE WOUNDS OR TO ACHIEVE HEMOSTASIS AND ONLY FOUR PATIENTS TOTAL IN THE VCD GROUP REQUIRED ADDITIONAL MANUAL COMPRESSION (MC) FOR HEMOSTASIS. THE 6FR ARTERIAL SHEATH SIZE WAS USED IN TWO PATIENTS AND A 7FR WAS USED IN THIRTY-TWO PATIENTS. THE DURATION OF THE PCI PROCEDURE COMPLETED IN LESS THAN 60 MINUTES (6 PATIENTS), BETWEEN 60-120 MINUTES (14 PATIENTS), AND GREATER THAN 120 MINUTES (14 PATIENTS). FOURTEEN PATIENTS HAD A POSTOPERATIVE USE OF ANTICOAGULANTS. HEMOSTASIS WAS SUCCESSFUL AFTER PCI WITH ALL THIRTY-FOUR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072385 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