BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1232169 · Received November 14, 2008

    Report

    Report Number
    3003681312-2008-00119
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    September 10, 2008
    Report Date
    November 13, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED; THEREFORE, AN EVALUATION COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION PROVIDED BY ST. JUDE MEDICAL, 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. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATES THAT IF THROMBOSIS 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 ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS THE USER TO OBSERVE STERILE TECHNIQUE AT ALL TIMES WHEN USING THE DEVICE. THE USE OF THE DEVICE WHERE BACTERIAL CONTAMINATION OF THE PROCEDURE SHEATH OR SURROUNDING TISSUES MAY HAVE OCCURRED MAY CAUSE INFECTION. ANY SIGN OF INFECTION AT THE PUNCTURE SITE SHOULD BE TAKEN SERIOUSLY AND THE PATIENT MONITORED CAREFULLY. SURGICAL REMOVAL OF THE DEVICE SHOULD BE CONSIDERED WHENEVER AN ACCESS SITE INFECTION IS SUSPECTED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES; IF PATIENTS 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. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (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. THE ANGIO-SEAL PATIENT INFO GUIDE INSTRUCTS THE PT TO REMOVE THE DRESSING AFTER 24 HOURS AND CLEAN THE AREA WITH MILD SOAP AND WATER AND DRY THE AREA. THE SITE SHOULD BE COVERED WITH A BAND-AID AND CHANGED DAILY OR IF IT BECOMES WET, UNTIL THE SKIN HEALS. THE PT IS ALSO INSTRUCTED TO CONTACT THE PHYSICIAN IMMEDIATELY IF THEY DEVELOP A FEVER, PERSISTENT TENDERNESS IN THE GROIN OR SWELLING, WOUND DRAINAGE, OR REDNESS AND/OR WARMTH AT THE SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A CORONARY CATHETERIZATION, A 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP WAS PLACED IN THE RIGHT FEMORAL ARTERY. A PRE-INSERTION FEMORAL ANGIOGRAM REVEALED NO EXTRAVASATION OF DYE AND THE SHEATH WAS ADEQUATELY POSITIONED. FOLLOWING THE DEPLOYMENT, THE PATIENT EXPERIENCED BLEEDING AND MANUAL COMPRESSION WAS APPLIED. THE PATIENT WAS SENT HOME, AND INITIALLY FELT FAIRLY WELL. THE PATIENT BEGAN HAVING RIGHT LEG PAIN ESPECIALLY WITH EXERTION. THE DOPPLER REVEALED THE PATIENT'S ANKLE BRACHIAL INDEX WAS MARKEDLY DIMINISHED ON THE RIGHT LEG (0.38). ANGIOGRAPHIC ASSESSMENT REVEALED OCCLUSION OF THE RIGHT COMMON FEMORAL ARTERY WITH RECONSTITUTION OF THE FEMORAL BIFURCATION VESSELS AND RUNOFF. ENDOVASCULAR ATTEMPTS AT CLEARING THIS OCCLUSION WERE UNSUCCESSFUL. THE PT WAS REFERRED AND COUNSELED TO UNDERGO SURGICAL REMOVAL OF THE RIGHT FEMORAL OCCLUSIVE LESION. THE PATIENT WAS HOSPITALIZED, GIVEN AN IV HEPARIN BOLUS, AND TAKEN TO THE OPERATING ROOM. GENERAL ANESTHESIA WAS ADMINISTERED. THE FEMORAL ARTERY WAS OPENED LONGITUDINALLY AND ACUTE ORGANIZED THROMBUS PRESENT. FLOW WAS THEN RESTORED TO THE RIGHT LEG. DORSALIS PEDIS PULSE WAS PRESENT WITH DOPPLER AND NO RIGHT FEMORAL PULSE. THE RIGHT FOOT WAS PINK WITH GOOD CAPILLARY REFILLING OF THE TOES. THE GROIN INCISION WAS IRRIGATED WITH BACITRACIN SOLUTION AND THE SUBCUTANEOUS LAYERS WERE CLOSED. THE PATIENT WAS REPORTED IN GOOD CONDITION. FOURTEEN DAYS AFTER SURGERY, THE PATIENT WAS READMITTED TO THE HOSPITAL WITH COMPLAINTS OF A SEROSANGUINEOUS TYPE OF DRAINAGE FROM THE CLOSED RIGHT GROIN INCISION. A CT SCAN OF THE ABDOMEN AND PELVIS REVEALED A 7 CM SIZE COMPLEX CYSTIC-TYPE MASS. THE PATIENT WAS PLACED ON IV ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLORATION AND EVACUATION OF A RIGHT GROIN HEMATOMA. THE HEMATOMA WAS FOUND AT THE BASE OF THE RIGHT FEMORAL ARTERY PATCH ANGIOPLASTY. CULTURES WERE OBTAINED, THE HEMATOMA DRAINED, AND A DRAIN WAS PLACED. THE PATIENT TOLERATED THE PROCEDURE WELL.

    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 2152757

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R