BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR RADIAL ACCESS SET

    MDR report key: 5021772 · Received August 21, 2015

    Report

    Report Number
    1820334-2015-00518
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    July 30, 2015
    Report Date
    July 30, 2015
    Manufacturer
    COOK INC
    Product Code
    DYB
    PMA / PMN Number
    K132392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    MODEL#: KCFN-6.0-18-13-RA-S-HC. (B)(4). INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION AND QUALITY CONTROL WAS CONDUCTED FOR THE PURPOSE OF THIS INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO ASSIST WITH THE INVESTIGATION. THERE ARE MULTIPLE CONTROLS IN PLACE TO MINIMIZE VALVE LEAKAGE. PER QUALITY CONTROL, FINAL INSPECTION FOR CHECK-FLO VALVE ASSEMBLY REQUIRES TO "PERFORM AN AIR PRESSURE TEST ON 100% FROM EACH ORDER RECEIVED." / "PERFORM AN AIR PRESSURE TEST ON 100% FROM EACH ORDER RECEIVED." / "VISUALLY EXAMINE THE DISC AND ENSURE THAT IT IS CLEAN AND FREE OF DEBRIS AND CORRECTLY POSITIONED IN THE CENTER OF CAP." AS PART OF COOK INCORPORATED¿S QUALITY SYSTEM PROCEDURES, EACH COMPLAINT IS INVESTIGATED AND AS PART OF THE INVESTIGATION, RISK IS ASSESSED, BASED ON SEVERITY, DETECT-ABILITY AND OCCURRENCE. BASED ON THIS ANALYSIS, ACTION TAKEN MAY INCLUDE THE FOLLOWING: CONTINUED MONITORING OF SIMILAR EVENTS, CORRECTIVE ACTION OR PREVENTATIVE ACTION. WITHOUT THE BENEFIT OF A RETURNED DEVICE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL.

    Description of Event or Problem · 1

    DURING A PCI VIA RADIAL ARTERY PROCEDURE, AFTER INSERTING THE INTRODUCER, THE HAEMOSTATIC VALVE BEGAN TO LEAK. 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 A PCI VIA RADIAL ARTERY PROCEDURE, AFTER INSERTING THE INTRODUCER, THE HAEMOSTATIC VALVE BEGAN TO LEAK. 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
    554017 FLEXOR RADIAL ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1