BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR RADIAL ACCESS SET

    MDR report key: 6204927 · Received December 27, 2016

    Report

    Report Number
    1820334-2016-01608
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    December 6, 2016
    Report Date
    June 7, 2017
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002356085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510K: K152044. ACRONYM ONLY WAS PROVIDED ON INITIAL REPORT. A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DEVICE HISTORY RECORD, DOCUMENTATION, TRENDS, QUALITY CONTROL, AND VISUAL INSPECTION / FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. A USED FLEXOR RADIAL ACCESS SET SHEATH AND DILATOR WERE RETURNED FOR INVESTIGATION. BIOMATTER WAS PRESENT ON THE CHECK-FLO ASSEMBLY AND WITHIN THE CONNECTING TUBE OF THE SHEATH. THE SHEATH PROXIMAL FITTING APPEARED TO HAVE A SILICONE DISC, AND NOT A BLUE VALVE. THEREFORE, THE CHECK-FLO WAS DISASSEMBLED (AFTER PERFORMING THE LEAK TEST) TO BETTER VISUALIZE THE DISC, WHICH CONFIRMED THAT THE DEVICE WAS ASSEMBLED WITH A SILICONE DISC. A LEAK TEST WAS PERFORMED ON THE COMPLAINT DEVICE BY OCCLUDING THE SHEATH TUBING WITH HEMOSTATS AND INJECTING WATER THROUGH THE CONNECTING TUBE ASSEMBLY USING A SYRINGE. LEAKAGE WAS OBSERVED THROUGH THE CENTER OF THE DISC. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THERE WAS ONE OTHER REPORTED COMPLAINT FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION VIA RADIAL APPROACH PROCEDURE, THE HAEMOSTATIC VALVE WAS LEAKING BLOOD BADLY WHEN THE DILATOR WAS REMOVED. THE INTRODUCER WAS EXCHANGED AND THE PROCEDURE CONTINUED WITH NO HARM TO PATIENT REPORTED.

    Description of Event or Problem · 1

    DURING A PCI VIA RADIAL APPROACH PROCEDURE, THE HAEMOSTATIC VALVE WAS LEAKING BLOOD BADLY WHEN THE DILATOR WAS REMOVED. THE INTRODUCER WAS EXCHANGED AND THE PROCEDURE CONTINUED WITH NO HARM TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857135 FLEXOR RADIAL ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC N/A 00827002356085

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR