BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL VASCULAR CLOSURE DEVICE

    MDR report key: 3417781 · Received October 11, 2013

    Report

    Report Number
    2182269-2013-00095
    Event Type
    Injury
    Date Received
    October 11, 2013
    Report Date
    September 26, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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 INFO RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS PUBLISHED IN AN ONLINE ARTICLE ON (B)(6) 2013 BY THE (B)(6) ASSOCIATION OF CARDIOVASCULAR INTERVENTION AND THERAPEUTICS 2013, TITLED "A CASE OF INTERMITTENT CLAUDICATION ASSOCIATED WITH THE ANGIO-SEAL VASCULAR CLOSURE DEVICE AFTER CAROTID ARTERY STENTING". THE INFO INDICATED A (B)(6) MALE WITH A HISTORY OF DIABETES MELLITUS UNDERWENT PERCUTANEOUS ARTERY STENTING OF THE RIGHT INTERNAL CAROTID ARTERY STENTING OF THE RIGHT INTERNAL CAROTID ARTERY VIA FEMORAL APPROACH USING A 8F VASCULAR SHEATH. THE PHYSICIAN TRIED TO SEAL THE ARTERIOTOMY IN THE RIGHT FEMORAL ARTERY WITH AN ANGIO-SEAL. THE ANCHOR WAS PROPERLY PLACED AND THE DEVICE WAS WITHDRAWN, BUT HEMOSTASIS WAS NOT ACHIEVED. MANUAL COMPRESSION WAS APPLIED AND HEMOSTASIS WAS ACHIEVED. UPON AMBULATING THE NEXT DAY, THE PT FELT SLIGHT LEG PAIN, YET WAS DISCHARGED ON DAY 7. THE PT WAS READMITTED ON DAY 13 AS THE LEG PAIN HAD WORSENED. PHYSICAL EXAM REVEALED REDUCED RIGHT FEMORAL PULSE WITH BRUIT. A LOWER LIMB ARTERIOGRAPHY AND ULTRASOUND WERE PERFORMED AND IT WAS DECIDED THAT A SURGICAL REMOVAL OF THE OBSTRUCTION WAS NECESSARY. INTRAOPERATIVELY, THE ANCHOR OF THE ANGIO-SEAL SURROUNDED BY THROMBUS WAS IDENTIFIED AND REMOVED FROM INSIDE THE VESSEL. MICROSCOPIC EVAL REVEALED THE THROMBUS CONTAINED THE COLLAGEN AND THE SUTURE. DOI 10.1007/S129828-013-0211-Y.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521436 ANGIO-SEAL VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R