BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULA 78320 EOPA 3D 20FR

    MDR report key: 3914878 · Received July 4, 2014

    Report

    Report Number
    2184009-2014-00050
    Event Type
    Malfunction
    Date Received
    July 4, 2014
    Date of Event
    June 3, 2014
    Report Date
    September 25, 2014
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWF
    PMA / PMN Number
    K061254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE IMAGES PROVIDED BY THE CUSTOMER AND THEIR DESCRIPTION OF THE EVENT, IT WAS CONFIRMED THAT THERE WAS DAMAGE TO THE CANNULA IN THE NARROWER SECTION OF THE BODY. THE SPLIT WAS IN THE OUTER LUMEN OF THE DEVICE AND DID NOT CONTINUE THROUGH THE INNER LUMEN. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. MEDTRONIC HAS INITIATED A FORMAL INVESTIGATION INTO RECENT EVENTS INVOLVING DAMAGE TO THE OUTER LUMEN OF EOPA ARTERIAL CANNULAE. AT THIS TIME, THERE HAVE NOT BEEN ANY REPORTS OF DAMAGE TO THE INNER LUMEN OF ANY OF THE CANNULAE, ANY LEAKS, OR ANY ADVERSE PATIENT EFFECTS AS A RESULT OF THESE ISSUES. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT RETURN HAS BEEN REQUESTED, BUT THE CANNULA HAS NOT YET BEEN RECEIVED. MEDTRONIC AND THE CONTRACT MANUFACTURER FOR THIS DEVICE HAVE INITIATED AN INVESTIGATION INTO THE EVENT. AFTER COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION INDICATING THAT DURING THE CASE, THIS EOPA ARTERIAL CANNULA WAS USED TO CANNULATE A GRAFT. THE PROCEDURE PROCEEDED NORMALLY, BUT WHEN THE SURGEON INITIALLY ATTEMPTED TO REMOVE THE CANNULA, IT WOULD NOT MOVE. AFTER A SHORT PERIOD OF MANIPULATION, THE CANNULA WAS DISLODGED. UPON EXAMINATION, THE SURGEON NOTED THAT THERE WAS DAMAGE TO THE OUTER BODY OF THE CANNULA. THE SURGEON INDICATED HE DID NOT FEEL THE PRODUCT WAS AT FAULT AND THAT THE CANNULA HAD POSSIBLY SUFFERED MECHANICAL DAMAGE FROM A CLAMP. THERE WAS A SHORT PERIOD OF DECREASED PRESSURE AS THE CANNULA WAS REMOVED, BUT IT QUICKLY RESOLVED AND THERE WERE NO LONG-TERM ADVERSE PATIENT EFFECTS. PRODUCT RETURN HAS BEEN REQUESTED, BUT THE CANNULA HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION INDICATING THAT DURING THE CASE, THIS EOPA ARTERIAL CANNULA WAS USED TO CANNULATE A GRAFT. THE PROCEDURE PROCEEDED NORMALLY, BUT WHEN THE SURGEON INITIALLY ATTEMPTED TO REMOVE THE CANNULA, IT WOULD NOT MOVE. AFTER A SHORT PERIOD OF MANIPULATION, THE CANNULA WAS DISLODGED. UPON EXAMINATION, THE SURGEON NOTED THAT THERE WAS DAMAGE TO THE OUTER BODY OF THE CANNULA. THE SURGEON INDICATED HE DID NOT FEEL THE PRODUCT WAS AT FAULT AND THAT THE CANNULA HAD POSSIBLY SUFFERED MECHANICAL DAMAGE FROM A CLAMP. THERE WAS A SHORT PERIOD OF DECREASED PRESSURE AS THE CANNULA WAS REMOVED, BUT IT QUICKLY RESOLVED AND THERE WERE NO LONG-TERM ADVERSE PATIENT EFFECTS. PHOTOGRAPHS OF THE PRODUCT WERE RECEIVED, BUT THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392820 CANNULA 78320 EOPA 3D 20FR CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF PERFUSION SYSTEMS 78320 201309C757

    Patients

    Seq Age Sex Outcome Treatment
    1