BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK SERIES

    MDR report key: 8487375 · Received April 5, 2019

    Report

    Report Number
    3008452825-2019-00154
    Event Type
    Injury
    Date Received
    April 5, 2019
    Report Date
    April 5, 2019
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR INVESTIGATION.  A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER IS UNAVAILABLE. BASED ON THE INFORMATION PROVIDED TO ABBOTT, THE REPORTED PERFORATION AND EXTRAVASATION COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN CARDIOVASC INTERVENT RADIOL IN AN ARTICLE TITLED ¿APPROACH, TECHNICAL SUCCESS, COMPLICATIONS, AND STENT PATENCY OF SHARP RECANALIZATION FOR THE TREATMENT OF CHRONIC VENOUS OCCLUSIVE DISEASE: EXPERIENCE IN 123 PATIENTS" BY MCDEVITT, J, SRINIVASA, R, GEMMETE, J, ET AL., 20 NOVEMBER 2018. "...IN 1 (0.8%) PROCEDURE, THERE WAS PERFORATION OF THE RIGHT BRACHIOCEPHALIC VEIN WITH RESULTING RIGHT HEMOTHORAX DURING A SUCCESSFUL RECANALIZATION OF AN OCCLUDED RIGHT JUGULAR VEIN WITH A TRANSSEPTAL NEEDLE AND LOOP SNARE, MANAGED WITH PLACEMENT OF A 10 MM 9 4 CM FLUENCY. COVERED STENT (BARD, MURRAY HILL, NJ) AND UNCOMPLICATED PLACEMENT OF CHEST TUBE. THERE WERE 7/123 (5.7%) MINOR ADVERSE EVENTS, WHICH INCLUDED 4 (3.3%) CASES OF SELF-LIMITED RETROPERITONEAL EXTRAVASATION AND 1 (0.8%) CASE EACH OF SELF-CONTAINED EXTRAVASATION INTO THE MEDIASTINUM, PELVIS, AND LEFT UPPER ARM" (DOI: HTTPS://DOI.ORG/10.1007/S00270-018-2090-1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281814 TRANSSEPTAL NEEDLE, BRK SERIES TRANSSEPTAL NEEDLE DRC ST. JUDE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other