BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGATOR¿

    MDR report key: 5183274 · Received October 28, 2015

    Report

    Report Number
    3005099803-2015-03047
    Event Type
    Malfunction
    Date Received
    October 28, 2015
    Date of Event
    September 28, 2015
    Report Date
    October 7, 2015
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KOG
    PMA / PMN Number
    K030956
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, AFTER WITHDRAWAL OF THE PROCEDURAL INSTRUMENTS, THE INSIDE OF THE SHEATH APPEARED TO BE SHREDDED. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NAVIGATOR ACCESS SHEATH WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, AFTER WITHDRAWAL OF THE PROCEDURAL INSTRUMENTS, THE INSIDE OF THE SHEATH APPEARED TO BE SHREDDED. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714648 NAVIGATOR¿ ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - SPENCER M0062502000

    Patients

    Seq Age Sex Outcome Treatment
    1