BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS OUS

    MDR report key: 3883732 · Received June 6, 2014

    Report

    Report Number
    3003681312-2014-00037
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 16, 2014
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFO REC'D, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE INFO PROVIDED TO SJM INDICATED A 6F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE FOLLOWING A PERCUTANEOUS PERIPHERAL INTERVENTION ON (B)(6) 2014. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THE PUNCTURE SITE WAS DISTAL TO THE INGUINAL LIGAMENT. THE ANGIOSEAL WAS DEPLOYED VIA A CONTRALATERAL APPROACH TO THE RIGHT SUPERFICIAL FEMORAL ARTERY AND HEMOSTASIS WAS ACHIEVED. THREE DAYS AFTER THE PROCEDURE, THE PT WAS DISCHARGED. TWO DAYS AFTER DISCHARGE (FIVE DAYS POST-PROCEDURE), BLEEDING OCCURRED DURING A MEAL AT HOME. THE PT RETURNED TO THE HOSPITAL, AND IT WAS DISCOVERED A HEMATOMA HAD DEVELOPED. HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION FOR 30 MINS. THE PT WAS HOSPITALIZED FOR OBSERVATION AND WAS DISCHARGED TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331135 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS OUS 6F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL PUERTO RICO, B.V. 610120 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization