BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAILBLAZER

    MDR report key: 4120830 · Received September 26, 2014

    Report

    Report Number
    2183870-2014-00241
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 29, 2014
    Manufacturer
    COVIDIEN PLYMOUTH
    Product Code
    DQY
    PMA / PMN Number
    K092299
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN (B)(6). IT WAS REPORTED ON (B)(6) 2014 THAT THERE WAS NO MARKER. DURING INVESTIGATION OF THE RETURNED DEVICE ON (B)(6) 2014 IT WAS FOUND THAT THE TRAILBLAZER CATHETER WAS RECEIVED FOR EVALUATION WITHOUT THE SECTION OF THE CATHETER CONTAINING THE MARKER BANDS. THE TRAILBLAZER EXHIBITED SIGNS OF ELONGATION/STRETCHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601880 TRAILBLAZER CATHETER, PERCUTANEOUS, DQY COVIDIEN PLYMOUTH SC-014-150 9835816

    Patients

    Seq Age Sex Outcome Treatment
    1 Other