BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENTSON STRAIGHT FIXED CORE WIRE GUIDE

    MDR report key: 20401993 · Received October 8, 2024

    Report

    Report Number
    1820334-2024-01316
    Event Type
    Malfunction
    Date Received
    October 8, 2024
    Report Date
    February 20, 2025
    Manufacturer
    COOK INC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. B3: DATE OF EVENT = BETWEEN 01JUN2024 AND 11SEP2024 G4: PMA/510(K) NUMBER = K171764. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    SUMMARY OF EVENT: AS REPORTED, DURING UNKNOWN PROCEDURES, AN UNSPECIFIED NUMBER OF BENTSON STRAIGHT FIXED CORE WIRE GUIDES HAVE BEEN "MALFUNCTIONING". REPORTEDLY, WHEN THE WIRES ARE GRASPED AND STRAIGHTENED, THE DISTAL END WILL NOT STRAIGHTEN, AND THE WIRES BEGIN TO SEPARATE AT THE POINT OF CONTACT. ACCESS IS "TYPICALLY" OBTAINED IN THE RIGHT GROIN AND ANOTHER MANUFACTURER'S CATHETER IS USED WITH THE WIRES. STENOSIS, TORTUOSITY, CALCIFICATION, AND SCARRING OF THE ANATOMY HAVE NOT BEEN CONSISTENT IN THE CASES, AND RESISTANCE HAS NOT BEEN ENCOUNTERED UPON INSERTION OF THE WIRES. THE WIRES HAVE NOT BEEN PULLED OR MANIPULATED BACKWARDS THROUGH A NEEDLE OR OTHER METAL INSTRUMENT DURING THE PROCEDURES. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE(S) WERE NOT RETURNED TO COOK FOR INVESTIGATION. A GLOBAL SHIPMENT SEARCH ON THE USER FACILITY AND COMPLAINT DEVICE WAS PERFORMED BUT COULD NOT DEFINITIVELY DETERMINE THE LOT NUMBER OF THE COMPLAINT DEVICE(S); THEREFORE, A SEARCH OF COMPLAINT HISTORY COULD NOT BE CONDUCTED. AT THIS TIME, COOK COULD NOT CONCLUDE THAT NONCONFORMING PRODUCT FROM THE AFFECTED LOT(S) EXISTS IN HOUSE OR IN THE FIELD. THE DEVICE INSTRUCTIONS FOR USE (IFU) STATES, ¿ALTERING THE TIP¿S CONFIGURATION OR CURVE MANUALLY MAY DAMAGE THE WIRE GUIDE.¿ A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR AND IFU SUGGESTS THAT THERE IS EVIDENCE THE DEVICE(S) WERE MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT COMPONENT FAILURE, UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THESE INCIDENT(S). THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    AS REPORTED, DURING UNKNOWN PROCEDURES, AN UNSPECIFIED NUMBER OF BENTSON STRAIGHT FIXED CORE WIRE GUIDES HAVE BEEN "MALFUNCTIONING". REPORTEDLY, WHEN THE WIRES ARE GRASPED AND STRAIGHTENED, THE DISTAL END WILL NOT STRAIGHTEN AND THE WIRES BEGIN TO SEPARATE AT THE POINT OF CONTACT. ACCESS IS "TYPICALLY" OBTAINED IN THE RIGHT GROIN AND ANOTHER MANUFACTURER'S CATHETER IS USED WITH THE WIRES. STENOSIS, TORTUOSITY, CALCIFICATION, AND SCARRING OF THE ANATOMY HAVE NOT BEEN CONSISTENT IN THE CASES, AND RESISTANCE HAS NOT BEEN ENCOUNTERED UPON INSERTION OF THE WIRES. THE WIRES HAVE NOT BEEN PULLED OR MANIPULATED BACKWARDS THROUGH A NEEDLE OR OTHER METAL INSTRUMENT DURING THE PROCEDURES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685770 BENTSON STRAIGHT FIXED CORE WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G01290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SOS ANGIODYNAMICS CATHETER.