BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BROCKENBROUGH NEEDLE

    MDR report key: 5547163 · Received April 5, 2016

    Report

    Report Number
    1220452-2016-00019
    Event Type
    Injury
    Date Received
    April 5, 2016
    Date of Event
    February 20, 2015
    Report Date
    March 7, 2016
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DRC
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS AORTIC IATROGENIC PERFORATION DURING TRANSSEPTAL PUNCTURE AND SUCCESSFUL OCCLUSION WITH AMPLATZER DUCTAL.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A PROCEDURE THE AORTIC ROOT WAS FORCEFULLY PUNCTURED WITH A BROCKENBROUGH NEEDLE. CATHETERIZATION WAS PERFORMED. THE ATRIAL SEPTUM WAS THICKER THAN NORMAL AND NO STENT WAS VISUALIZED. THE BROCKENBROUGH NEEDLE SLIPPED FROM DE FOSSA OVALIS AND, INADVERTENTLY THE AORTIC ROOT WAS FORCEFULLY PUNCTURED. AN 8-FR MULLINS SHEATH WAS IMMEDIATELY ADVANCED FOLLOWING THE PUNCTURE. IT WAS DECIDED TO LEAVE THE 8-FR SHEATH IN THE AORTIC ROOT RECOGNIZING THE DANGER OF REMOVING THE SHEATH. FINALLY A 6/4 MM NON-MEDTRONIC DUCTAL OCCLUDER WAS ADVANCED THROUGH THE MULLINS SHEATH AND UNDER FLUOROSCOPY AND TEE GUIDANCE, A SUCCESSFUL DEPLOYMENT OF THE DEVICE AND CLOSURE OF THE PERFORATION WAS ACHIEVED. SUBSEQUENTLY, THE PARAVALVULAR LEAK WAS CLOSED WITH AN NON-MEDTRONIC VASCULAR PLUG. THE PHYSICIAN ASSESSED THAT THE PERFORATION WAS BECAUSE OF A MISTAKE BY THE SURGICAL TEAM, AND THE PATIENT ANATOMY NEVER CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203913 BROCKENBROUGH NEEDLE TROCAR DRC MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention