BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR RADIAL ACCESS SET

    MDR report key: 7110807 · Received December 12, 2017

    Report

    Report Number
    1820334-2017-04484
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    December 11, 2017
    Report Date
    March 30, 2018
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002356030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND A VISUAL INSPECTION AND FUNCTIONAL EVALUATION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE DILATOR WAS NOT PRESENT IN THE RETURNED SAMPLE. THE DEVICE WAS TESTED FOR LEAKAGE, AND IT WAS NOTICED THAT SEEPAGE AT THE DISK OCCURRED. THE PROXIMAL FITTING WAS DISASSEMBLED FOR FURTHER EXAMINATION. THE SLIT IN THE DISC INTERSECTS WITH THE CENTER HOLE, BUT THE SLIT DOES NOT APPEAR RUN EDGE TO EDGE. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER = K152044. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER COMPLETION OF A PERIPHERAL CORONARY INTERVENTION ANGIOPLASTY, ANOTHER MANUFACTURER'S SIX (6) FR CATHETER AND WIRE GUIDE WERE REMOVED FROM THE FLEXOR RADIAL ACCESS SET SHEATH, AND THE VALVE WAS OBSERVED TO BE BROKEN AND LEAKING BLOOD. ACCORDING TO THE INITIAL REPORTER, NO PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT, NOR DID THE PATIENT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889080 FLEXOR RADIAL ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC 00827002356030

    Patients

    Seq Age Sex Outcome Treatment
    1