BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP (OUS)

    MDR report key: 3201490 · Received June 28, 2013

    Report

    Report Number
    2182269-2013-00052
    Event Type
    Injury
    Date Received
    June 28, 2013
    Report Date
    June 7, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE SERIAL NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS THAT IF ANCHOR FRACTURE OR EMBOLISM IS SUSPECTED, THE DEVICE SHOULD BE EXAMINED TO DETERMINE IF THE ANCHOR HAS BEEN WITHDRAWN. IF BLEEDING OCCURS, APPLY MANUAL OR MECHANICAL PRESSURE TO THE PUNCTURE SITE PER STANDARD PROCEDURES. IF THE ANCHOR IS NOT ATTACHED TO THE DEVICE, MONITOR THE PATIENT (FOR AT LEAST 24 HOURS) FOR SIGNS OF VASCULAR OCCLUSION. SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATE THAT BLEEDING OR A HEMATOMA AT THE PUNCTURE SITE ARE A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCTS THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE AND IF NECESSARY, MONITOR PEDAL PULSES.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED A 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE WAS SELECTED FOR USE FOLLOWING A DIAGNOSTIC CATHETERIZATION. THE DEVICE WAS DEPLOYED IN THE COMMON FEMORAL ARTERY, BUT THE BLEEDING CONTINUED. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. AFTER THE PATIENT HAD LEFT THE CATH LAB, IT WAS OBSERVED THAT THERE WAS ABSENCE OF PEDAL PULSES. THE PATIENT UNDERWENT SURGERY TO REMOVE THE DEVICE AND BLOOD FLOW WAS RESTORED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION FOLLOWING THE PROCEDURE AND DISCHARGED AFTER AN EXTENDED HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296804 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP (OUS) NONE MGB ST. JUDE MEDICAL 610132 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R