BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2051192 · Received April 6, 2011

    Report

    Report Number
    2182269-2011-00061
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    October 1, 2010
    Report Date
    April 6, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED AND AN ANGIO-SEAL WAS SELECTED FOR CLOSURE. THE PRE-INSERTION ANGIOGRAM WAS UNREMARKABLE AND THE PUNCTURE TO THE COMMON FEMORAL ARTERY WAS AN APPROPRIATE 4MM IN SIZE. A FEW MINUTES AFTER DEPLOYMENT, THE PATIENT WAS COMPLAINING OF A COLD LEG. AN ULTRASOUND WAS PERFORMED, WHICH REVEALED A LACK OF BLOOD FLOW NEAR THE LOCATION WHERE THE ANGIO-SEAL WAS DEPLOYED. THE SAME AFTERNOON, A CT SCAN WAS PERFORMED, WHICH REVEALED THE SAME RESULTS AS THE ULTRASOUND, A LACK OF BLOOD FLOW. LATER THAT SAME EVENING, THE PATIENT UNDERWENT SURGERY AND THE ANGIO-SEAL WAS REMOVED. THE PATIENT WAS REPORTED TO BE FINE AFTER SURGERY. THE EVENT, IMPLANT, AND EXPLANT DATES WERE MONTH SPECIFIC, OCCURRING SOMETIME IN (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R