BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 3780682 · Received April 18, 2014

    Report

    Report Number
    3003681312-2014-00025
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 25, 2014
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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 BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFO RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE INFO PROVIDED TO SJM INDICATED A 6F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE IN THE PT'S RIGHT FEMORAL ARTERIOTOMY ON (B)(6) 2014. THE PT PRESENTED ON (B)(6) 2014 WITH A COLD AND PAINFUL LOWER EXTREMITY. AN ANGIOGRAM SHOWED COMPLETE OCCLUSION OF THE RIGHT COMMON FEMORAL ARTERY. ATTEMPTS WERE MADE TO CROSS OCCLUSION AND GIVE MEDICATIONS TO RESOLVE THE FILLING DEFECT. THE PT WAS KEPT OVERNIGHT AND RETURNED TO THE CATH LAB ON (B)(6) 2014 TO RE-EVALUATE. THE RUN OFF VESSELS APPEARED IMPROVED BUT A FILLING DEFECT REMAINED IN THE COMMON FEMORAL ARTERY. EXPLORATORY SURGERY AND REPAIR WAS SCHEDULED FOR (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238881 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 6F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL, PUERTO RICO, B.V. 610119 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R