BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1970137 · Received January 13, 2011

    Report

    Report Number
    3003681312-2011-00003
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    November 1, 2010
    Report Date
    January 13, 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
    AS
    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) CAUTIONS, 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) STATE THAT BASED ON CLINICAL EXPERIENCE, THROMBOSIS AT THE PUNCTURE SITE IS A RISK OR SITUATION ASSOCIATED WITH THE USE OF THE ANGIO-SEAL DEVICE OR VASCULAR ACCESS PROCEDURES. IF THROMBUS AT THE PUNCTURE SITE IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS EVENT MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION. THE ANGIOSEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT THE SAFETY AND EFFECTIVENESS OF THE ANGIO-SEAL DEVICE HAS NOT BEEN ESTABLISHED FOR PATIENTS UNDERGOING AN INTERVENTIONAL PROCEDURE WHOM ARE BEING TREATED WITH WARFARIN. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT THE ANGIO-SEAL KIT IS SUPPLIED STERILE IN A POLYFOIL BAG. THE BAG INCLUDES A SEALED TRAY CONTAINING THE ANGIO-SEAL COMPARTMENTS. THE ANGIO-SEAL IS LABELED STERILE. THE ANGIO-SEAL DEVICE PATIENT'S INFORMATION GUIDE, WHICH THE PATIENT IS INSTRUCTED TO CARRY WITH THEM FOR 90 DAYS, INSTRUCTS THE PATIENT 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-AGE AND CHANGED DAILY OR IF IT BECOMES WET, UNTIL THE SKIN HEALS. THE PATIENT 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 AN ANGIO-SEAL STS PLUS WAS DEPLOYED IN THE PATIENT'S ARTERIOTOMY FOLLOWING A DIAGNOSTIC ANGIOGRAM. THE PATIENT RETURNED TO THE HOSPITAL 4 DAYS LATER WITH A THROMBUS WOUND. THE PATIENT HAD A THROMBECTOMY AND WAS IN THE HOSPITAL WITH A WOUND INJURY AND WOUND DRESSING. THE IMPLANT DATE AND EVENT DATE ARE MONTH SPECIFIC., THE EXACT DATE WAS UNKNOWN. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THE INCIDENT DATE AND IMPLANT DATE ARE MONTH SPECIFIC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R THE PATIENT WAS ON WARFIN AND HEPARIN (DOSES UNK)