BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2914910 · Received January 9, 2013

    Report

    Report Number
    2182269-2013-00001
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 20, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 INSTRUCTIONS FOR US (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATE THAT IF COLLAGEN DEPOSITION INTO THE ARTERY OR THROMBOSIS AT THE PUNCTURE SITE IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE AND DEPLOYED SUCCESSFULLY INTO A RETROGRADE PUNCTURE IN THE LEFT FEMORAL ARTERY AT THE CONCLUSION OF A PERIPHERAL ANGIOGRAM, REVEALING A SUITABLE VESSEL. HEMOSTASIS WAS IMMEDIATE, PEDAL PULSES WERE VERIFIED, AND THE PT WAS LATER DISCHARGED THE SAME DAY WITHOUT ANY COMPLICATIONS. THE PT CALLED LATER, REPORTING LEG PAIN AND TINGLING, AND PRESENTED THE NEXT DAY, WHERE TESTING REVEALED NO BLOOD FLOW DISTAL TO THE PUNCTURE SITE. VASCULAR SURGERY REVEALED THE COLLAGEN WAS INSIDE THE ARTERY AND AN ENDARTERECTOMY WAS PERFORMED TO REMOVE THE BLOOD CLOT FROM THE FEMORAL ARTERY. THE PT RECOVERED WITHOUT FURTHER COMPLICATION AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13045 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R