BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR RADIAL ACCESS SET

    MDR report key: 6395696 · Received March 10, 2017

    Report

    Report Number
    1820334-2017-00373
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    February 8, 2017
    Report Date
    August 21, 2017
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002355989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) # : K152044. THE REPORTED DEVICE HAS BEEN RECEIVED, AN EVALUATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4).. A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, TRENDS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. TWO FLEXOR RADIAL ACCESS SET SHEATHS FROM LOT 4844427 WERE RETURNED TOGETHER FOR INVESTIGATION WITH INSERTED DILATORS (1820334-2017-00372 AND 1820334-2017-00373, CANNOT BE DISTINGUISHED). IT WAS FOUND THAT THE TUBING AT THE DISTAL TIP OF EACH SHEATH HAD BUCKLED, RESULTING IN AN UNSMOOTH TRANSITION BETWEEN EACH SHEATH AND DILATOR. IT IS FEASIBLE TO SUGGEST THAT THIS FAILURE OCCURRED UPON INSERTION OF THE DEVICES INTO THE PATIENTS. USING A 10X MAGNIFIER, THE GROUND TAPERS FOR THE SHEATHS WERE MEASURED TO BE SIGNIFICANTLY SMALLER THAN INDICATED IN THE APPROPRIATE DRAWING. WHILE THE SHEATH TAPERS WERE FOUND TO BE MANUFACTURED OUT OF SPECIFICATION (I.E. TOO SHORT), IT CANNOT BE CONFIRMED THAT THE ROOT CAUSE OF THIS EVENT IS ASSOCIATED WITH THIS NONCONFORMANCE. IT IS POSSIBLE THAT OTHER FACTORS, SUCH AS PATIENT ANATOMY (SCAR TISSUE, CALCIFICATION, ETC.) COULD HAVE CONTRIBUTED TO THE REPORTED EVENT AS WELL. 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. MEASURES HAVE BEEN CONDUCTED TO ADDRESS THIS FAILURE MODE. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CARDIAC CATHETER EXAMINATION, THAT WHEN INSERTING THE FLEXOR RADIAL ACCESS SETS SHEATH, THE TIP OF THE CATHETER WAS NOTED TO BE UNEVEN AND IT WAS NOT POSSIBLE TO INSERT THE INTRODUCERS. IT WAS ALSO NOTED THAT THE TIP OF THE CATHETER STARTED TO DISSOLVE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178157 FLEXOR RADIAL ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC N/A 00827002355989

    Patients

    Seq Age Sex Outcome Treatment
    1