BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1060376 · Received June 11, 2008

    Report

    Report Number
    3003681312-2008-00063
    Event Type
    Injury
    Date Received
    June 11, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 13, 2008
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST. JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATE THAT BLEEDING OR A HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USED OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCT THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE. IF NECESSARY, MONITOR PEDAL PULSES. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTION, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATE IF RE-PUNCTURE AT THE SAME LOCATION OF PREVIOUS ANGIO-SEAL DEVICE IS NECESSARY IN LESS THAN OR EQUAL TO 90 DAYS, RE-ENTRY SHOULD BE ONE CM PROXIMAL TO THE PREVIOUS ACCESS SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 6F ANGIO-SEAL VIP WAS USED TO SEAL THE RIGHT COMMON FEMORAL ARTERIOTOMY (RCFA). TEN DAYS PRIOR, THE PT HAD AN INTERVENTIONAL PROCEDURE AND AN ANGIO-SEAL SEALED THE RCFA WITHOUT INCIDENT. THE DAY BEFORE THAT PROCEDURE, THE PT ALSO HAD AN INTERVENTIONAL PROCEDURE IN WHICH A PERCLOSE WAS USED TO SEAL THE RCFA WITHOUT INCIDENT. AFTER THE THIRD PROCEDURE, HEMOSTASIS WAS NOT ACHIEVED WITH THE 6F ANGIO-SEAL AND MANUAL PRESSURE WAS UTILIZED. THE PT WAS SENT TO THE NURSING FLOOR AND APPROX ONE HR LATER, THE PT HAD A COLD FOOT AND LEG. A SURGEON WAS CALLED AND THE PT WAS TAKEN TO THE OPERATING ROOM WHERE BOTH ANGIO-SEALS AND THE PERCLOSE WERE REMOVED. THE PT WAS REPORTED TO BE DOING WELL, POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 2056295

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention