BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1940490 · Received December 21, 2010

    Report

    Report Number
    2182269-2010-00245
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTION THAT A PSEUDOANEURYSM ARE POSSIBLE RISK OR SITUATION ASSOCIATED WITH THE USE OF THE ANGIO-SEAL DEVICE OR VASCULAR ACCESS PROCEDURES. IF SUSPECTED, THESE CONDITIONS MAY BE EVALUATED WITH DUPLEX ULTRASOUND. WHEN INDICATED, ULTRASOUND-GUIDED COMPRESSION OF A PSEUDOANEURYSM MAY BE USED AFTER THE ANGIO-SEAL DEVICE HAS BEEN PLACED. POTENTIAL CAUSES OF A PSEUDOANEURYSM MAY INCLUDE A LOW OR INCOMPLETE STICK INTO THE ARTERY FOR ACCESS OR THE PT'S PREDISPOSITION TO PSEUDOANEURYSM FORMATION. AS THE PRODUCT WAS NOT RETURNED, OUR INVESTIGATION WAS LIMITED TO THE INVESTIGATION OF THE DEVICE HISTORY RECORDS WHICH SHOWS FULL COMPLIANCE WITH SPECIFICATIONS. BASED ON THE AVAILABLE INFO, WE WERE NOT ABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE FOR THE EVENT. WE HAVE THEREFORE, NO EVIDENCE OF DEVICE MALFUNCTION OR ANY DEFICIENCY WITH THE INSTRUCTIONS FOR USE REQUIRING CORRECTIVE ACTION. WE WILL CONTINUE TO CLOSELY MONITOR THE PERFORMANCE OF THE DEVICE AND WILL NOT HESITATE TO INFORM IN CASE AN ABNORMAL TREND WOULD BE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED PT RECEIVED A 6F ANGIO-SEAL VIP IN THE RIGHT FEMORAL ARTERIOTOMY. THE PHYSICIAN WAS NEWLY CERTIFIED ON THE ANGIO-SEAL EVOLUTION DEVICE, BUT WAS IN THE ANGIO-SEAL VIP TRAINING PROCESS. THE DEVICE WAS DEPLOYED AND HEMOSTASIS WAS ACHIEVED. THERE WERE NO PROBLEMS WITH DEPLOYMENT. THE PT WAS RELEASED HOME LATER THAT EVENING. ON (B)(6) 2010 THE PT COMPLAINED OF PAIN, SWELLING AND PURPLE-BLACK COLORS FORMING AROUND HIS GROIN AREA AND LEG. THE PT ALSO EXPERIENCED RIGHT SIDED PAIN AND SWELLING OF THE RIGHT FOOT. ON (B)(6) 2010 THE PT WAS SEEN BY THE PHYSICIAN AND DIAGNOSED A PSEUDOANEURYSM AND THE PT RECEIVED AN INJECTION OF RECHOTHROM, DOSE UNK. THE PT WAS RELEASED AND HIS CONDITION WAS REPORTED TO BE FINE.

    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 NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention