BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPLEGE CORONARY SINUS CATHETER

    MDR report key: 2880444 · Received December 19, 2012

    Report

    Report Number
    3008500478-2012-00348
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    5120780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS DISCARDED BY THE HOSPITAL PRIOR TO INVESTIGATION. THE PRODUCT WAS NOT RETURNED AND THE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS DEVICE. THEREFORE A CAPA WAS NOT INITIATED FOR THIS EVENT. THIS INFORMATION WILL BE INCLUDED IN TRENDING AND FUTURE CAPA DETERMINATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICAL SPECIALIST THAT OVER THE PAST 2 MONTHS, UNKNOWN DATES THERE WAS A CORONARY SINUS DISSECTION WITH THE USE OF THE PROPLEGE CORONARY SINUS CATHETER, PR9. WHILE THE MD WAS TRYING TO ADVANCE THE PR9 INTO THE DISTAL CORONARY SINUS. THE MD ENGAGED THE OSTIUM OF THE CORONARY SINUS EASILY, BUT EXPERIENCED DIFFICULTY ADVANCING THE PR9. HE EXPERIENCED RESISTANCE AND CONTINUED TO TRY TO ADVANCE THE PR9, RESULTING IN A PATIENT INJURY. THEY ARE CALLING THE INJURY A DISSECTION OF THE CORONARY SINUS. THE LOT NUMBER IN UNKNOWN. NO SURGERY WAS NEEDED TO FIX THE DISSECTION. THE PATIENT RECOVERED WELL. NO PRODUCT IS AVAILABLE FOR RETURN, IT WAS DISCARDED BY THE HOSPITAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other