BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR RADIAL ACCESS SET

    MDR report key: 4698693 · Received April 13, 2015

    Report

    Report Number
    1820334-2015-00205
    Event Type
    Injury
    Date Received
    April 13, 2015
    Date of Event
    March 19, 2015
    Report Date
    March 19, 2015
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    PMA / PMN Number
    K132392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L 510 (K): K132592 - FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET. PER INFORMATION SUPPLIED BY THE CUSTOMER, NO PRODUCT WILL BE RETURNED. A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE PAMPHLET (IFU) AND QUALITY CONTROL ACTIVITIES (QC) WAS COMPLETED DURING THE INVESTIGATION. THIS PRODUCT IS SHIPPED WITH AN IFU WHICH STATES UNDER PRECAUTIONS SECTION THAT ALL INSTRUMENTS OR CATHETERS USED WITH THIS PRODUCT SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. DAMAGE TO THE VALVE/INTRODUCER MAY RESULT WHEN THE FIT IS TIGHT. THERE IS NO EVIDENCE TO SUGGEST THAT THE PRODUCT WAS NOT MANUFACTURED TO SPECIFICATIONS. WE ARE INCONCLUSIVE AS TO WHY THIS FAILURE MODE OCCURRED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND MONITORING FOR SIMILAR COMPLAINTS WILL CONTINUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AFTER INSERTING THE SHEATH VIA RADIAL ACCESS ON A FEMALE PATIENT WITHOUT INCIDENT, THE PHYSICIAN WAS UNABLE TO WITHDRAW THE SHEATH AT END OF PROCEDURE. THE PHYSICIAN REMOVED THE SHEATH BY SURGICAL INTERVENTION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244872 FLEXOR RADIAL ACCESS SET DYB INTRODUCER, CATHETER DYB COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention