BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1912323 · Received November 16, 2010

    Report

    Report Number
    2182269-2010-00203
    Event Type
    Injury
    Date Received
    November 16, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ST. JUDE MEDICAL
    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

    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 TO ST JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTION FOR USE (IFU) STATES SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE IFU INSTRUCTS THE USER ONCE A FULL REAR LOCK POSITION HAS BEEN ACHIEVED, AND THE DEVICE IS BEING DEPLOYED, TO NOT RE-INSERT THE DEVICE. RE-INSERTION OF THE DEVICE AFTER PARTIAL DEPLOYMENT COULD CAUSE COLLAGEN TO BE DEPOSITED IN THE ARTERY. THE IFU ALSO STATES FAILURE TO MAINTAIN TENSION ON THE SUTURE WHILE ADVANCING THE COLLAGEN COULD CAUSE THE COLLAGEN TO ENTER THE ARTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) USING AN ANTEGRADE APPROACH, A 6F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE. IT IS UNK WHETHER OR NOT A PRE-ANGIOGRAM WAS PERFORMED. DURING DEPLOYMENT, THE BLACK COMPACTION MARKER WAS NOT EXPOSED. WHILE THE PHYSICIAN CONTINUED TO ADVANCE THE COLLAGEN WITHIN THE TAMPER TUBE, HE WAS NOT FULLY ABLE TO MAINTAIN TENSION ON THE SUTURE, WHICH CAUSED THE COLLAGEN TO PROTRUDE INTO THE ARTERY. THE PATIENT EXPERIENCED A 100% OCCLUSION AND THE ANGIO-SEAL WAS SURGICALLY REMOVED. THE PATIENT HAS RECOVERED. THE PHYSICIAN WAS IN THE TRAINING PROCESS FOR THE ANGIO-SEAL STS PLUS. THE PATIENT'S SUBCUTANEOUS TISSUE WAS NOT THIN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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 NA 3129880

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention