BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE CORONARY SINUS CATHETER

    MDR report key: 2880068 · Received December 19, 2012

    Report

    Report Number
    3008500478-2012-00347
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 6, 2012
    Report Date
    February 1, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    5120780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE CATHETER WAS VISUALLY INSPECTED AND FOUND THE TIP OF THE CATHETER WAS STUCK INSIDE THE CONTAMINATION GUARD CAP OF THE CATHETER NO DEVICE DEFECTS WERE CONFIRMED. THE ROOT CAUSE OF THE DIFFICULTIES EXPERIENCED IN THIS CASE CAN MOST LIKELY BE ATTRIBUTED TO THE USER KINKING THE TIP OF THE DEVICE DURING USE. CAPA NOT REQUIRED PER ASSESSMENT. NO CORRECTIVE ACTIONS DUE TO THIS COMPLAINT. THE INFORMATION GATHERED DURING THIS REPORTED EVENT AND EVALUATION WILL BE INCLUDED IN TRENDING DATA FOR FUTURE CAPA DETERMINATIONS. INSTRUCTIONS FOR USE WERE REVIEWED AND FOUND ACCEPTABLE. THE LOT NUMBER OF THE DEVICE IN QUESTION IS UNKNOWN; THEREFORE, A DHR REVIEW CANNOT BE COMPLETED. FROM (B)(4) 2012 (PROPLEGE LAUNCH) TO DATE, THERE HAVE BEEN NO OTHER COMPLAINTS REGARDING THE BALLOON OF THE PROPLEGE DEVICE BEING ECCENTRIC OR HAVING FOREIGN MATTER ATTACHED TO IT. (B)(4). 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 IS CURRENTLY UNDER EVALUATION INTO ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE CARDIOPLEGIA WAS NOT BEING DELIVERED TO ARREST THE HEART. PER THE REP IT APPEARED AS THE BALLOON OF THE PROPLEGE CORONARY SINUS CATHETER WAS NOT COMPLETELY ROUND AND THERE WAS A "PIECE SEWN TO THE SIDE" OF THE BALLOON. NO PATIENT INJURY WAS REPORTED.

    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