BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BROCKENBROUGH NEEDLE

    MDR report key: 6431353 · Received March 24, 2017

    Report

    Report Number
    1220452-2017-00021
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    November 22, 2014
    Report Date
    February 24, 2017
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DRC
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL TITLE: TRANSSEPTAL ACCESS IN PEDIATRIC AND CONGENITAL ELECTROPHYSIOLOGY PROCEDURES: DEFINING RISK AUTHORS: JOHANNES C. VON ALVENSLEBEN <(>&<)> MACDONALD DICK II <(>&<)> DAVID J. BRADLEY <(>&<)> MARTIN J. LAPAGE REFERENCE: J INTERV CARD ELECTROPHYSIOL (2014) 41:273¿277 DOI 10.1007/S10840-014-9946-3. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING A CARDIAC CATHETER ABLATION PROCEDURE WHICH WAS ACHIEVED BY TRANSSEPTAL PUNCTURE (TSP) USING THE BROCKENBROUGH PROCEDURE, NEEDLE PERFORATION OF THE POSTERIOR WALL OF THE LEFT ATRIUM OCCURRED. FEMORAL VENOUS SHEATH ACCESS WAS USED. CONTRAST WAS INJECTED AND OPACIFIED THE PERICARDIAL SPACE. THE DILATOR AND SHEATH WERE NOT ADVANCED AND THE NEEDLE WAS WITHDRAWN. THE CASE WAS COMPLETED SUCCESSFULLY THROUGH A SECOND TSP SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213948 BROCKENBROUGH NEEDLE TROCAR DRC MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization