BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1003857 · Received February 20, 2008

    Report

    Report Number
    3003681312-2008-00011
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    October 15, 2007
    Report Date
    October 15, 2007
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    p930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WAS RETURNED. A REVIEW OF THE LOT HISTORY REVEALED NO OTHER INCIDENTS WITH THIS LOT #. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO REC'D, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTION FOR USE (IFU) STATE THAT IF THE COLLAGEN DISPOSITION INTO THE ARTERY OR THROMBOSIS AT THE PUNCTURE SITE IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) INSTRUCT 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, FAILURE TO MAINTAIN TENSION ON THE SUTURE WHILE COMPACTING THE COLLAGEN COULD CAUSE COLLAGEN TO ENTER THE ARTERY. ALSO, FAILURE TO MAINTAIN TENSION ON THE SUTURE WHILE COMPACTING THE COLLAGEN COULD CAUSE COLLAGEN TO ENTER THE ARTERY. THE ANGIO-SEAL DEVICE INSTRUCTION OF USE (IFU) CAUTION, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANGIO-SEAL WAS USED TO CLOSE THE RIGHT FEMORAL ARTERY (RFA) POST LEFT HEART CATHETERIZATION. THE DEVICE WAS DEPLOYED WITHOUT ANY DIFFICULTIES. DURING POST ASSESSMENT, DIMINISHED PULSES WERE NOTED. THIRTY TO FORTY MINS POST PROCEDURE, THE PT REPORTED LEG PAIN. THE PHYSICIAN WAS NOTIFIED AND THE PT WAS TAKEN BACK TO THE CATH LAB. COLLAGEN WAS FOUND IN THE RFA. REPAIR WAS ATTEMPTED BY THE PHYSICIAN; HOWEVER, IT WAS UNSUCCESSFUL. A SURGEON WAS NOTIFIED AND THE PT WAS TAKEN TO SURGERY FOR EXPLORATION OF THE RFA WITH POSSIBLE EMBOLECTOMY AND REMOVAL OF COLLAGEN FROM THE ARTERY. ST JUDE MEDICAL PROD SURVEILLANCE WAS MADE AWARE OF THIS EVENT JANUARY 23, 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL PUERTO RICO, B.V. NA 2023632

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention ANTICOAGULANTS