BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR RADIAL ACCESS SET

    MDR report key: 5225804 · Received November 16, 2015

    Report

    Report Number
    1820334-2015-00750
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Date of Event
    October 9, 2015
    Report Date
    October 23, 2015
    Manufacturer
    COOK INC
    Product Code
    DYB
    PMA / PMN Number
    K132392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, TRENDS AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS RETURNED TO ASSIST IN THE INVESTIGATION AND WAS LEAK TESTED. LEAK TESTING SHOWED THE DEVICE LEAKED SEVERAL DROPS FROM THE CENTER OF THE BLUE VALVE AFTER A DILATOR WAS INTRODUCED THROUGH THE VALVE. PRIOR TO THE INTRODUCTION OF THE DILATOR, THE DEVICE DID NOT APPEAR TO LEAK. THE VALVE DID NOT APPEAR DAMAGED PRIOR TO LEAK TESTING. THE BLUE VALVE USED IN THIS DEVICE WAS MADE OBSOLETE ON 19 NOVEMBER 2015 AND WAS REPLACED WITH A CLEAR SILICONE DISC. A QUALITY ENGINEERING RISK ASSESSMENT FOUND THAT THE RISK TO BENEFIT RATIO ON DEVICES MANUFACTURED WITH THE PREVIOUS VALVE REMAINED ACCEPTABLE. LOT 6011958 WAS MANUFACTURED PRIOR TO THIS CHANGE, THEREFORE THE BLUE POLYISOPRENE VALVE WAS USED FOR MANUFACTURING. THE ROOT CAUSE IS DETERMINED TO BE COMPONENT-RELATED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED, AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, BLOOD LEAKED THROUGH HAEMOSTATIC VALVE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, BLOOD LEAKED THROUGH HAEMOSTATIC VALVE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT铠BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755764 FLEXOR RADIAL ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1