BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 3140898 · Received May 24, 2013

    Report

    Report Number
    2182269-2013-00040
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    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) STATES IF PATIENT'S HAVE CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE, BASED ON PUBLISHED MEDICAL LITERATURE, THE ANGIO-SEAL DEVICE CAN BE DEPLOYED SAFELY IN PATIENT ARTERIES >5MM DIAMETER WHEN THERE IS FOUND TO BE NO LUMINAL NARROWING OF 40% OR GREATER WITHIN 5MM OF THE PUNCTURE SITE.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE. THE DEVICE WAS DEPLOYED IN THE RIGHT FEMORAL ARTERY WITH SOME RESIDUAL BLEEDING OBSERVED. MANUAL COMPRESSION WAS HELD FOR 10 MINUTES LEADING TO HEMOSTASIS. FOLLOWING COMPRESSION, PEDAL PULSES WERE WEAK TO ABSENT. A RIGHT LEG ANGIOGRAM WAS PERFORMED REVEALING A FLOW DEFECT ABOVE THE PUNCTURE SITE. A RETRIEVAL DEVICE WAS USED IN AN ATTEMPT TO REMOVE THE OBJECT CAUSING THE WEAK FLOW PHENOMENON. THIS ATTEMPT WAS UNSUCCESSFUL AND THE NEXT ANGIOGRAM SHOWED A POSSIBLE VESSEL DISSECTION. A BALLOON WAS INSERTED TO COMPRESS THE DISSECTION AND THE PATIENT WAS PUT ON TISSUE PLASMINOGEN ACTIVATOR (TPA) AND KEPT OVERNIGHT. THE FOLLOWING DAY, MILD BRUISING WAS OBSERVED AND PEDAL PULSES HAD RETURNED. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231150 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R