BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL EVOLUTION

    MDR report key: 1990878 · Received February 10, 2011

    Report

    Report Number
    2182269-2011-00020
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 19, 2010
    Report Date
    February 10, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 6F ANGIO-SEAL EVOLUTION HEMOSTASIS SHEATH AND CARRIER TUBE ASSEMBLY WERE VISUALLY INSPECTED AND FUNCTIONALLY TESTED/EVALUATED. THE CARRIER TUBE ASSEMBLY HAD BEEN FULLY INSERTED INTO THE HEMOSTASIS SHEATH AND WAS IN THE FULL REAR-LOCK POSITION; THE GEARBOX ASSEMBLY WAS IN THE "OUT OF PARK" POSITION. THE COMPACTION MARKER WAS FULLY EXPOSED. THE INTACT SUTURE LOOP, COLLAGEN MASS, AND KNOT WERE IN DIRECT CONTACT WITH THE COMPACTION TUBE DISTAL END. THE ANCHOR WAS NOT ATTACHED. NO OTHER CONTRIBUTING VISUAL ANOMALIES WERE NOTED. THE DEVICE WAS DISASSEMBLED. NO VISUAL ANOMALIES WERE NOTED IN THE SUTURE ROUTING, GEARS, GEAR MESH, OR RELATED MECHANISM. THE DEVICE WAS FUNCTIONALLY TESTED FOR GEAR ROTATION, RACK ADVANCEMENT, CLUTCH SLIPPAGE, AND SUTURE RELEASE; NO FUNCTIONAL ANOMALIES WERE NOTED. THE CONDITION OF THE DEVICE IS CONSISTENT WITH ANCHOR DETACHMENT DURING USE OF THE DEVICE WHICH WOULD RESULT IN A LOSS OF TENSION AND THE CORRESPONDING INCOMPLETE SUTURE UNSPOOLING CONDITION OBSERVED ON THE RETURNED DEVICE. HOWEVER, THE CONDITION OF THE ANCHOR ATTACHMENT AND UNSPOOLED SUTURE COULD NOT CONCLUSIVELY BE DETERMINED TO BE MANUFACTURING RELATED. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THERE WAS NO EVIDENCE FOUND TO SUGGEST THE INCIDENT WAS DUE TO AN INTRINSIC DEFECT IN THE DEVICE, AS SUPPORTED BY THE REVIEW OF THE MANUFACTURING TRAVELER AND THE ANALYSIS PERFORMED. THE CAUSE OF THE REPORTED INCIDENT REMAINS UNK. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATES THAT IF THE DEVICE PULLS OUT WITH SHEATH UPON WITHDRAWAL, APPLY MANUAL OR MECHANICAL PRESSURE PER STANDARD PROCEDURE. EXAMINE THE DEVICE TO ENSURE ALL ABSORBABLE COMPONENTS HAVE BEEN WITHDRAWN. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT IF ANCHOR FRACTURE OR EMBOLISM IS SUSPECTED, THE USER SHOULD EXAMINE THE DEVICE TO DETERMINE IF THE ANCHOR HAS BEEN WITHDRAWN. IF BLEEDING OCCURS, APPLY MANUAL OR MECHANICAL PRESSURE TO THE PUNCTURE SITE PER STANDARD PROCEDURES. IF THE ANCHOR IS NOT ATTACHED TO THE DEVICE, MONITOR THE PT (FOR AT LEAST 24 HOURS) FOR SIGNS OF VASCULAR OCCLUSION. CLINICAL EXPERIENCE TO DATE INDICATES THAT TISSUE ISCHEMIA FROM AN EMBOLIZED ANCHOR IS UNLIKELY. SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENT, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANGIO-SEAL WAS DEPLOYED AFTER A DIAGNOSTIC LEFT HEART CATHETERIZATION. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. AFTER DEPLOYMENT OF THE ANGIO-SEAL ANCHOR, AS THE PHYSICIAN PULLED BACK THE DEVICE, ALL OF THE ANGIO-SEAL COMPONENTS PULLED OUT OF THE PT. MANUAL COMPRESSION WAS HELD FOR 22 MINS. HEMOSTASIS WAS OBTAINED WITH NO COMPLICATIONS NOTED. THE PT, HOWEVER, WAS ADMITTED OVERNIGHT, DUE TO NECESSARY BED REST AFTER MANUAL COMPRESSION OF THE ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL EVOLUTION ANGIO-SEAL VASCULAR CLOSURE DEVICE MGB ST. JUDE MEDICAL NA 3187330

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization