BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 3140897 · Received May 24, 2013

    Report

    Report Number
    2182269-2013-00039
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    February 1, 2013
    Report Date
    April 30, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE SERIAL 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 USE (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS THE USE OF THE ANGIO-SEAL DEVICE IF THERE IS SUSPICION THAT THE INTRODUCER HAS BEEN PLACE THROUGH THE SUPERFICIAL FEMORAL ARTERY AND INTO THE PROFUNDA FEMORIS. COLLAGEN DEPOSITION INTO THE SUPERFICIAL FEMORAL ARTERY COULD RESULT, WHICH MAY REDUCE THE BLOOD FLOW THROUGH THE VESSEL. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) PRECAUTION THAT IF THE PUNCTURE SITE IS AT OR DISTAL TO THE BIFURCATION OF THE SUPERFICIAL FEMORAL AND PROFUNDA FEMORIS ARTERY, AS THIS MAY RESULT IN THE ANGIO-SEAL DEVICE ANCHOR CATCHING ON THE BIFURCATION FEMORAL AND PROFUNDA FEMORIS ARTERY, AS THIS MAY RESULT IN THE ANGIO-SEAL DEVICE ANCHOR CATCHING ON THE BIFURCATION OR BEING POSITIONED INCORRECTLY, AND/OR COLLAGEN DEPOSITION IN THE VESSEL. THESE EVENTS MAY REDUCE BLOOD FLOW THROUGH THE VESSEL LEADING TO SYMPTOMS OF DISTAL ARTERIAL INSUFFICIENCY.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI) THROUGH A 5F INTRODUCER IN THE RIGHT FEMORAL ARTERY. THE ANGIO-SEAL WAS DEPLOYED WITHOUT INCIDENT. THE PATIENT WAS MONITORED OVERNIGHT AND DISCHARGED THE FOLLOWING DAY. FOUR WEEKS AFTER ANGIO-SEAL DEPLOYMENT, THE PATIENT WAS READMITTED AND DIAGNOSED WITH AN OCCLUSION OF THE FEMORAL SUPERFICIALIS AND TREATED SUCCESSFULLY WITH ATHERECTOMY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE PATIENT IS CURRENTLY RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231712 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R