BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE

    MDR report key: 6173100 · Received December 14, 2016

    Report

    Report Number
    2182269-2016-00046
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    May 3, 2016
    Report Date
    November 26, 2016
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THIS INVESTIGATION CONCLUDED THE CARRIER TUBE ASSEMBLY HAD BEEN FULLY INSERTED INTO THE HEMOSTASIS SHEATH AND WAS IN THE FULL REAR LOCK POSITION. THE TAMPER TUBE, ANCHOR AND COLLAGEN WERE NOT RETURNED. THE SUTURE WAS RETURNED DETACHED. THE CLEAR HEAT SHRINK TUBE WAS EXPOSED ON THE SUTURE. THE SUTURE BROKE INTO MULTIPLE FRAGMENTS DURING HANDLING CONSISTENT WITH MATERIAL DEGRADATION DUE TO CHEMICAL AND/OR HEAT EXPOSURE SUBSEQUENT TO REMOVAL FROM THE POLY-FOIL POUCH. THE OVERALL DEVICE CONDITION WAS CONSISTENT WITH DEPLOYMENT. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE INCIDENT WAS DUE TO AN INTRINSIC DEFECT IN THE RETURNED DEVICE. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING SJM MANUFACTURING FACILITIES AS SUPPORTED BY A REVIEW OF THE DEVICE HISTORY RECORD. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATE THAT BLEEDING OR A HEMATOMA AT THE PUNCTURE SITE ARE A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE AND IF NECESSARY, MONITOR PEDAL PULSES.

    Description of Event or Problem · 1

    A HEMATOMA OCCURRED AT THE FEMORAL PUNCTURE SITE AFTER LEAVING THE PROCEDURE ROOM, FOLLOWING DEPLOYMENT OF A 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE. IT IS UNKNOWN HOW THE HEMATOMA WAS RESOLVED. IT WAS REPORTED THE PATIENT WAS RE-HOSPITALIZED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824664 ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL 610132 5384845

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization