BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1221223 · Received November 4, 2008

    Report

    Report Number
    3003681312-2008-00107
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    November 14, 2007
    Report Date
    November 4, 2008
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUMENT FOR USE (IFU) STATES THAT BLEEDING OR HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE. IF NECESSARY, MONITOR PEDAL PULSES. THE IFU STATES THAT IF COLLAGEN DEPOSITION INTO THE ARTERY AT THE PUNCTURE SITE IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION. THE IFU CAUTIONS SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE IFU STATES THE ANGIO-SEAL KIT IS SUPPLIED STERILE IN A POLY BAG. THE BAG INCLUDES A SEALED TRAY CONTAINING THE ANGIO-SEAL COMPONENTS. THE ANGIO-SEAL IS LABELED STERILE.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH RECEIPT OF AN INCOMPLETE LEGAL COMPLAINT THAT FOLLOWING A CARDIAC CATHETERIZATION A 6F ANGIO-SEAL VIP WAS DEPLOYED IN THE LEFT FEMORAL ARTERIOTOMY. ARTERIAL ACCESS FOR THE PROCEDURE WAS STATED AS BEING DIFFICULT. AFTER UNSUCCESSFUL ATTEMPTS IN THE RIGHT FEMORAL ARTERY, ACCESS WAS GAINED IN THE LEFT FEMORAL ARTERY AND A VENOUS SHEATH WAS PLACED IN THE RIGHT FEMORAL VEIN BECAUSE PERIPHERAL IV ACCESS HAD BEEN LOST. THE HEART CATHETERIZATION REVEALED A 20% OCCLUSION OF THE LEFT ANTERIOR DESCENDING ARTERY. DURING ANGIO-SEAL DEPLOYMENT, THE PATIENT COMPLAINED OF PAIN. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED PAIN AND A GROIN CHECK REVEALED A RIGHT LEG HEMATOMA. THE PATIENT WAS DISCHARGED. TWENTY SEVEN DAYS LATER, THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND WAS SEEN BY THE PHYSICIAN. THE PATIENT THEN REPORTED TO THE PHYSICIAN PROGRESSING SYMPTOMS OF LEFT LEG CLAUDICATION. WHICH BEGAN TWO DAYS AFTER THE HEART CATHETERIZATION. AN ULTRASOUND REVEALED AN ARTERIAL BLOCKAGE. THE PATIENT UNDERWENT A PATCH ANGIOPLASTY 20 DAYS LATER. ALLEGEDLY, A COLLAGEN LIKE MASS OF MATERIAL WAS REMOVED FROM THE BLOOD VESSEL AT THE SITE OF THE ANGIO-SEAL. TEN DAYS AFTER THE SURGERY, THE PATIENT DEVELOPED A WOUND DEHISCENCE. FOLLOWING SURGERY, THE PATIENT EXPERIENCED FURTHER LEFT LEG CLAUDICATION AND ADDITIONAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL PUERTO RICO, B.V. NA 2032708

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R