BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BROCKENBROUGH NEEDLE

    MDR report key: 8455157 · Received March 27, 2019

    Report

    Report Number
    1220452-2019-00035
    Event Type
    Injury
    Date Received
    March 27, 2019
    Date of Event
    November 20, 2018
    Report Date
    March 27, 2019
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DRC
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LIT REF: DOI.ORG/10.1007/S00270-018-2090-1. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    123 PATIENTS UNDERWENT SHARP RECANALIZATION OF CHRONIC VENOUS OCCLUSIONS. MEDTRONIC BROCKENBOROUGH TRANSEPTAL NEEDLE WAS AMONGST THE DEVICES USED. TECHNICAL SUCCESS WAS ACHIEVED IN 111 (90.2%) PATIENTS. THERE WERE 3 (2.4%) SEVERE, 1 (0.8%) MODERATE, AND 7 (5.7%) MINOR ADVERSE EVENTS. SEVERE ADVERSE EVENTS INCLUDED 1 CASE EACH OF PERICARDIAL TAMPONADE, HEMOTHORAX, AND INFERIOR VENA CAVA FILTER OCCLUSION. SPECIFICALLY, 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 NON-MEDTRONIC STENT AND UNCOMPLICATED PLACEMENT OF CHEST TUBE. IN 1 (0.8%) PROCEDURE, THERE WAS RE-OCCLUSION OF THE INFERIOR SEGMENT OF THE PATIENT¿S ALREADY-PRESENT INFERIOR VENA CAVA FILTER AFTER SUCCESSFUL SHARP RECANALIZATION OF AN OCCLUDED RIGHT ILIO-CAVAL CONFLUENCE, WHICH WAS TREATED SUCCESSFULLY WITH PHARMACOMECHANICAL THROMBOLYSIS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249091 BROCKENBROUGH NEEDLE TROCAR DRC MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention