BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE CORONARY SINUS CATHETER

    MDR report key: 4152967 · Received October 8, 2014

    Report

    Report Number
    3008500478-2014-00122
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 14, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IS CURRENTLY IN PROCESS. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION.

    Additional Manufacturer Narrative · 1

    RETURN DEVICE EVALUATION: THE DEVICE WAS RETURNED AND VISUALLY INSPECTED; THERE WERE NO KINKS, BENDS OR DEFORMITIES FOUND IN THE CATHETER SHAFT. DURING INSPECTION IT WAS NOTED THAT THE BALLOON INFLATION HOLE WAS MISSING. THE REPORTED COMPLAINT CONDITION COULD BE CONFIRMED AND A MANUFACTURING RELATED ISSUE WAS IDENTIFIED. PRODUCT RISK ASSESSMENT WAS PERFORMED AND A CORRECTIVE ACTION WAS OPENED TO ADDRESS THE ISSUE. ADDITIONAL MANUFACTURER NARRATIVE: DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THERE WERE NO NON-CONFORMANCES FOUND RELATED TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT, WHILE PREPPING THE PROPLEGE CORONARY SINUS CATHETER, THE BALLOON WOULD NOT INFLATE. ANOTHER PROPLEGE WAS USED IN ITS PLACE. THERE WERE NO PATIENT COMPLICATIONS, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632290 PROPLEGE CORONARY SINUS CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF EDWARDS LIFESCIENCES PR9 59793436

    Patients

    Seq Age Sex Outcome Treatment
    1