BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE

    MDR report key: 3852027 · Received June 5, 2014

    Report

    Report Number
    3008500478-2014-00083
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 21, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K120780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINICAL OBSERVATION WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE CORONARY SINUS PRESSURE EXTENSION LUMEN WAS DETACHED FROM THE TRIFURCATION OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THIS DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS. THE ROOT CAUSE OF THIS REPORT IS UNABLE TO BE DETERMINED. NO CAPA IS APPLICABLE AT THIS TIME. THE INSTRUCTIONS FOR USE, TRAINING, AND RISK CONTROL MEASURES ARE APPROPRIATE AT THIS TIME. TRENDS WILL CONTINUE TO BE MONITORED THROUGH THE EDWARDS QUALITY SYSTEM. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED UPON RECEIPT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF A PROPLEGE CORONARY SINUS CATHETER, PR9 IT WAS FOUND TO BE DEFECTIVE. IT WAS REPORTED THAT IT WAS ALMOST COMPLETELY SEVERED AT THE BASE OF THE WHITE CORONARY SINUS PRESSURE LINE. THE ISSUE WAS DISCOVERED DURING USE JUST AFTER PLACEMENT IT WAS NOTED THAT THE DEVICE WAS LEAKING AROUND THE WHITE CORONARY SINUS PRESSURE LINE. THE DEVICE WAS REMOVED A REPLACED WITH A NEW PR9. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329260 PROPLEGE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9 59683517

    Patients

    Seq Age Sex Outcome Treatment
    1