BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2212667 · Received August 10, 2011

    Report

    Report Number
    3003681312-2011-00060
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 INFORMATION PROVIDED TO ST. JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION 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 IN PATIENTS WITH CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PERCUTANEOUS PROCEDURE USING BILATERAL FEMORAL ARTERIAL PUNCTURES. THE PRE-DEPLOYMENT ANGIOGRAM REVEALED STENOSIS APPROXIMATELY 3 CM FROM THE RIGHT FEMORAL ARTERY PUNCTURE ACCESS POINT LOCATION. DURING THE PROCEDURE, THE PATIENT EXPERIENCED A COMPLICATION IN THEIR LEFT LEG. THE PATIENT WAS TAKEN TO THE OPERATING ROOM, WHERE THE PHYSICIAN CLOSED THE PUNCTURE SITE IN THE RIGHT LEG WITH AN ANGIO-SEAL. SHORTLY AFTER DEPLOYMENT, THE PATIENT HAD PAIN IN THEIR RIGHT LEG. AN ANGIOGRAM WAS PERFORMED, WHICH REVEALED A VESSEL OCCLUSION AT THE RIGHT FEMORAL ARTERY. AN AORTA VESSEL PROSTHESIS PROCEDURE WAS PERFORMED WHICH RESOLVED THE COMPLICATIONS IN BOTH LEGS. THE PATIENT'S HOSPITALIZATION WAS EXTENDED, BUT WAS REPORTED TO BE RECOVERING AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL PUERTO RICO, B.V. NA 3285809

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R