BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE CORONARY SINUS DEVICE

    MDR report key: 3021955 · Received March 26, 2013

    Report

    Report Number
    3008500478-2013-00412
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 26, 2013
    Report Date
    May 21, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    5120780
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE CATHETER WAS VISUALLY INSPECTED AND NO VISUAL DEFECTS WERE FOUND ON THE CATHETER. A FUNCTIONAL ARTICULATION TEST WAS PERFORMED BY ACTUATING THE THUMB SWITCH AND FOUND THAT THE TIP ARTICULATES AS NORMAL WHEN THE THUMB SWITCH IS MOVED THROUGH ITS VARIOUS POSITIONS. THE COMPLAINT IS NOT CONFIRMED. IT IS NOT KNOWN WHAT CAUSED THE CUSTOMER PERCEPTION THAT THE DEVICE WAS DEFECTIVE. NO CAPA REQUIRED PER CAPA ASSESSMENT AT THIS TIME. THE INSTRUCTIONS FOR USE APPROPRIATELY EDUCATE ON HOW TO USE THE DEVICE FOR PLACEMENT INTO THE CORONARY SINUS. TRENDS WILL CONTINUE TO BE MONITORED ON A MONTHLY BASIS AND IF FURTHER ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED UPON PRODUCT RETURN FROM THE CUSTOMER.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY AN EDWARDS' SALES REP: "A PROCEDURE WAS PERFORMED ON (B)(6) 2013, THE MD WAS IN CHARGE OF PLACING THE PROPLEGE CORONARY SINUS CATHETER. THE MD DID THE USUAL PREPPING OF THE CATHETER. THEY'VE POSITIONED THE PRODUCT USING TEE AND FLUOROSCOPY, AND HAD A FEW ISSUES WITH THE PLACEMENT BUT ENDED OUT POSITIONING THE TIP IF THE CATHETER TO A PROPER POSITION. DURING THE SURGERY, THEY WERE NOT VERY HAPPY WITH THE RETROGRADE CARDIOPLEGIA DELIVERY AND DECIDED TO SWITCH TO ANTEGRADE. UPON REMOVAL OF THE CATHETER, THEY REALIZED THAT THE ARTICULATING POSITIONING DIAL WAS NOT WORKING: WHEN THEY MOVED IT FROM POSITION TO POSITION, NOTHING WOULD CHANGE AT THE TIP. THEY HAD NOT CHECKED IT PRIOR TO INSERTION OR DURING PRODUCT PREPPING, SO DON'T KNOW IF IT WAS NOT WORKING FROM THE START." NO INJURY TO THE PATIENT REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123750 PROPLEGE CORONARY SINUS DEVICE CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9 59451225

    Patients

    Seq Age Sex Outcome Treatment
    1