BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1913739 · Received November 24, 2010

    Report

    Report Number
    3003681312-2010-00075
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATES, 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 THAT FOLLOWING A PERCUTANEOUS CARDIAC CATHETERIZATION, AN ANGIOGRAM OF THE RIGHT FEMORAL REGION WAS TAKEN FOR CLOSURE DEVICE. A 6F ANGIO-SEAL STS PLUS WAS DEPLOYED BY THE DOCTOR AND IT WAS OBSERVED THAT THE PT HAD A WEAK POSTERIOR TIBIAL (PT) PULSE AND NO PEDAL PULSE. IN ADDITION, THE PT HAD LEG PAIN AND THE LEG FROM ANKLE DOWN BECAME PALE IN COLOR. ACCORDING TO THE CARDIOLOGY FELLOWS AT ANOTHER HOSPITAL, THE PT HAD AN OCCLUSION OF THE COMMON FEMORAL ARTERY (CFA). THE PT UNDERWENT SURGERY ON (B)(6) 2010 AND WAS DISCHARGED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 6F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 3121839

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R