BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE

    MDR report key: 4130061 · Received September 30, 2014

    Report

    Report Number
    3003681312-2014-00097
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 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
    AS
    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. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT IN VERY THIN PATIENTS THE COLLAGEN MAY PROTRUDE FROM THE SKIN AFTER TAMPING HAS BEEN COMPLETED. ATTEMPT TO PUSH THE COLLAGEN UNDER THE SKIN USING THE TAMPER TUBE OR A STERILE HEMOSTAT. DO NOT APPLY VIGOROUS TAMPING AS THIS MAY RESULT IN ANCHOR FRACTURE. DO NOT CUT OFF THE EXCESS COLLAGEN, AS THE SUTURE WOVEN THROUGH THE COLLAGEN MAY BE CUT AND THE INTEGRITY OF THE ANCHOR/COLLAGEN SANDWICH COULD BE COMPROMISED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS THAT IF ANCHOR FRACTURE OR EMBOLISM IS SUSPECTED, THE DEVICE SHOULD BE EXAMINED TO DETERMINE IF THE ANCHOR HAS BEEN WITHDRAWN. IF BLEEDING OCCURS, APPLY MANUAL OR MECHANICAL PRESSURE TO THE PUNCTURE SITE PER STANDARD PROCEDURES. IF THE ANCHOR IS NOT ATTACHED TO THE DEVICE, MONITOR THE PATIENT (FOR AT LEAST 24 HOURS) FOR SIGNS OF VASCULAR OCCLUSION. SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE ON A THIN PATIENT IN THE SUPERFICIAL FEMORAL ARTERIOTOMY. THE ANGIO-SEAL DEPLOYED NORMALLY, BUT AFTER THE SUTURE WAS CUT AND THE COLLAGEN WAS COMPACTED, THE COLLAGEN WAS OBSERVED TO BE EXPOSED OUTSIDE THE SKIN. AFTER THE COLLAGEN WAS ATTEMPTED TO BE PUSHED UNDER THE SURFACE OF THE SKIN, THE ANCHOR AND COLLAGEN CAME LOOSE AND WERE SUSPECTED TO HAVE DISLODGED INTERNALLY. HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION. THE PATIENT WAS MONITORED IN THE HOSPITAL FOR 24 HOURS AND NO SIGNS OF LIMB ISCHEMIA WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607749 ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL PUERTO RICO, B.V. 610132 4590901

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization