BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2130233 · Received June 10, 2011

    Report

    Report Number
    2182269-2011-00101
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 10, 2011
    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

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT BLEEDING OR A HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE AND IF NECESSARY, MONITOR PEDAL PULSES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 6F ANGIO-SEAL VIP WAS SELECTED FOR CLOSURE OF THE RIGHT FEMORAL ARTERY. THE DEPLOYER STATED THAT HEMOSTASIS WAS ACHIEVED IMMEDIATELY FOLLOWING DEPLOYMENT, HOWEVER, THE PATIENT COUGHED WHEN HE WENT TO REMOVE THE VENOUS SHEATH FROM THE PATIENT. THIS ALLEGEDLY CAUSED AN IMMEDIATE BLEED. EVENTUALLY, THEY COULD NOT FEEL THE PATIENT'S PEDAL PULSES SO THEY HAD TO PERFORM SURGERY. THE PATIENT WAS FOUND TO HAVE A COMPLETE OCCLUSION OF THE COMMON FEMORAL ARTERY. A RIGHT THROMBOENDARTERECTOMY OF THE RIGHT FEMORAL ARTERY WITH REMOVAL OF THE ANGIO-SEAL WAS PERFORMED. HEMOSTASIS WAS ACHIEVED AND THERE WERE GOOD PULSES IN THE FOOT. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. THERE WERE NO COMPLICATIONS. THE PATIENT RECEIVED HEPARIN (UNKNOWN DOSAGE) DURING BOTH THE ANGIO-SEAL PROCEDURE AND SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention