BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 4092315 · Received August 19, 2014

    Report

    Report Number
    3003681312-2014-00067
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 30, 2014
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. 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THAT IF ANCHOR FRACTURE OR EMBOLISM IS SUSPECTED, THE DEVICE SHOULD BE EXAMINED TO DETERMINE IF THE ANCHOR HAS BEEN WITHDRAWN.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 PATIENT INFORMATION GUIDE STATES WITHIN 60-90 DAYS, THE ANCHOR, COLLAGEN SPONGE AND SUTURE OF THE ANGIO-SEAL DEVICE WILL NATURALLY BE REABSORBED BY THE BODY.

    Description of Event or Problem · 1

    A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE IN THE COMMON FEMORAL ARTERIOTOMY FOLLOWING A CARDIAC CATHETERIZATION. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. AFTER THE PULL-BACK STEP, AN UNKNOWN DEVICE COMPONENT EMBOLIZED IN THE VESSEL AND WAS CONFIRMED USING AN ULTRASOUND. IT WAS UNKNOWN IF THE ANCHOR DETACHED OR THE DEVICE WENT INTO THE VESSEL. THE PATIENT WAS TAKEN FOR VASCULAR REPAIR AND ATTEMPTS TO RETRIEVE THE DEVICE WERE UNSUCCESSFUL AS THE DEVICE HAD MIGRATED DISTAL TO THE PUNCTURE SITE. THE DEVICE WAS ELECTED NOT TO BE REMOVED SINCE THE PATIENT HAD GOOD PEDAL PULSES WITH NO ISCHEMIC SYMPTOMS. THE PATIENT WAS KEPT OVERNIGHT DUE TO STENT PLACEMENT AND WAS DISCHARGED THE FOLLOWING DAY IN STABLE CONDITION AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500415 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP DEVICE, HEMOSTATSIS, VASCULAR MGB ST. JUDE MEDICAL 610130 4612206

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R