BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1012647 · Received March 11, 2008

    Report

    Report Number
    3003681312-2008-00027
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    January 30, 2008
    Report Date
    February 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 6F ANGIO-SEAL STS PLUS HEMOSTASIS SHEATH AND CARRIER TUBE ASSEMBLY (INCLUDING DETACHED SHEATH, CARRIER TUBE, AND SUTURE SEGMENTS) WERE VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE CARRIER TUBE ASSEMBLY HAD BEEN FULLY INSERTED INTO THE HEMOSTASIS SHEATH AND WAS IN THE FULL REAR-LOCK POSITION. THE SHEATH TUBING, CARRIER TUBE, TAMPER TUBE, AND SUTURE WERE SEVERED 1.6" FROM THE HEMOSTASIS CAP DISTAL END, CONSISTENT WITH CUTTING. THE DETACHED SUTURE SEGMENT CONTAINED A SUTURE LOOP WHICH WAS SEVERED AT ITS DISTAL END, CONSISTENT WITH CUTTING. THE DEVICE WAS DISASSEMBLED. THE SUTURE WAS PROPERLY POSITIONED WITH NO EVIDENCE THAT IT HAD BEEN TANGLED, KNOTTED, OR RESTRAINED; A PORTION OF THE SUTURE REMAINED COILED WITHIN THE SUTURE WIND DISK. NO CONTRIBUTING ANOMALIES WERE NOTED IN THE SUTURE PATH, OR IN THE LOCATION/CONDITION OF ANY RELATED COMPONENT. THE DEVICE WAS REASSEMBLED AND THE SUTURE EXTRACTED; NO ANOMALIES WERE NOTED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION PROVIDED TO ST. JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE (PCI), AN ANGIO-SEAL WAS USED. A PRE-DEPLOYMENT ANGIOGRAM REVEALED NO ANOMALIES. THE PHYSICIAN EXPERIENCED A SUTURE LOCK-UP WHEN THE PHYSICIAN TRIED TO PULL THE SHEATH AND CARRIER TUBE FROM THE PUNCTURE SITE. THE PHYSICIAN SUSPECTED THAT THE ANCHOR WAS CAUGHT AT THE BIFURCATION; THEREFORE, THE SURGEON WAS CONSULTED. THE SURGEON MADE A SMALL INCISION IN THE ARTERY. THE PHYSICIAN CONFIRMED THAT THE ANCHOR WAS DEPLOYED CORRECTLY. THE REPRESENTATIVE PROVIDED TECHNICAL ASSISTANCE. THE ANCHOR AND COLLAGEN WERE NOT REMOVED. THE SURGEON CUT THE SUTURE AND CARRIER TUBE ABOVE THE ANCHOR AND THE SUTURE WAS REMOVED. THE SURGEON TRIED ANOTHER SUTURE TO SANDWICH THE ARTERY BETWEEN THE ANCHOR AND COLLAGEN. HEMOSTASIS WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 6F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. NA 2042425

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention