BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE

    MDR report key: 4130126 · Received September 30, 2014

    Report

    Report Number
    3003681312-2014-00096
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 5, 2014
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    PP930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES THAT IF THE ANGIO-SEAL DEVICE DOES NOT ANCHOR IN THE ARTERY DUE TO IMPROPER ORIENTATION OF THE ANCHOR OR PATIENT VASCULAR ANATOMY, THE ENTIRE ABSORBABLE COMPONENTS AND DELIVERY SYSTEM SHOULD BE WITHDRAWN FROM THE PATIENT. HEMOSTASIS CAN BE ACHIEVED BY APPLYING MANUAL PRESSURE.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE ON (B)(6) 2014. THERE WAS SOME DIFFICULTY EXPERIENCED AND THE ANGIO-SEAL WAS PARTIALLY DEPLOYED. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. ON (B)(6) 2014, SURGERY WAS PERFORMED FOR REMOVAL OF THE FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607914 ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL PUERTO RICO, B.V. 610130

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R