BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2896515 · Received December 28, 2012

    Report

    Report Number
    3003681312-2012-00086
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 10, 2012
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE 8F ANGIO-SEAL VIP HEMOSTASIS SHEATH AND CARRIER TUBE ASSEMBLY WERE VISUALLY INSPECTED AND FUNCTIONALLY TESTED/EVALUATED. THE DEPLOYMENT SLEEVE WAS IN THE EXTENDED AND LOCKED POSITION, BUT WAS NOT INSERTED INTO THE HEMOSTASIS CAP. HOWEVER, DAMAGE WAS NOTED TO BOTH THE DEPLOYMENT SLEEVE AND THE HEMOSTASIS CAP CONSISTENT WITH PRIOR INSERTION/LOCKING OF THE DEPLOYMENT SLEEVE INTO THE CAP AND SUBSEQUENT FORCIBLE EXTRACTION OF THE SAME. A LENGTH OF SUTURE EXITED THE CARRIER TUBE DISTAL TIP; THE DISTAL ENDS OF THE SUTURE WERE EVEN, CONSISTENT WITH CUTTING. THE CLEAR HEAT SHRINK TUBING WAS EXPOSED ON THE SUTURE. THE CARRIER TUBE ASSEMBLY WAS INSERTED INTO THE HEMOSTASIS SHEATH AND MOVED INTO THE FULL FORWARD-LOCK POSITION; POSITIVE ENGAGEMENT WAS VERIFIED, AND A DISTINCT "CLICK" WAS HEARD. NO ANOMALIES WERE NOTED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE USER ONCE A FULL REAR LOCK HAS BEEN ACHIEVED, AND THE DEVICE IS BEING DEPLOYED, DO NOT RE-INSERT THE DEVICE; RE-INSERTION OF THE DEVICE AFTER PARTIAL DEPLOYMENT COULD CAUSE COLLAGEN TO ENTER THE ARTERY. ALSO, ERRATIC, VIGOROUS TAMPING OR EXCESSIVE UPWARD TENSION ON THE SUTURE MAY RESULT IN COLLAGEN PLACEMENT IN THE ARTERY OR ANCHOR BREAKAGE. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE. WHEN THE CARRIER TUBE CAP WAS PULLED BACK TO SET THE ANCHOR, SHIFTING THE CARRIER TUBE SIDE TO SIDE, ONE OF THE DEVICE SLEEVES CAME UNLOCKED FROM THE SHEATH CAP. THE SLEEVE WAS PUSHED BACK TO RELEASE THE TAMPER TUBE. THE PHYSICIAN COMPLETED DEPLOYMENT, BUT THE ABSENCE OF A PEDAL PULSE WAS NOTED, REQUIRING SURGERY FOR DEVICE REMOVAL, WHICH REVEALED IMPROPER PLACEMENT OF THE ANGIO-SEAL COMPONENTS. THE PATIENT WAS STABLE FOLLOWING THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R