BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYB INTRODUCER, CATHETER

    MDR report key: 23223374 · Received October 6, 2025

    Report

    Report Number
    1820334-2025-01208
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    September 23, 2025
    Report Date
    February 12, 2026
    Manufacturer
    COOK INC
    Product Code
    DYB
    PMA / PMN Number
    K240589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, DURING AN UNKNOWN PROCEDURE, TWO UNSPECIFIED COOK "PEDAL KIT WIRES" BROKE. AN ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE THE SECOND BROKEN WIRE. ADDITIONAL INFORMATION WAS REQUESTED. D4: POSSIBLE CATALOG AND MODEL #S: MPIS-401-PEDAL-NT-U (G35548), MPIS-401-PEDAL-NT-U-SST (G02972), MPIS-501-PEDAL-NT-U (G35549), AND MPIS-501-PEDAL-NT-U-SST (G02988) D4: POSSIBLE LOT #S: 16488521, 16648120, 16588647, OR16642362. INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY FOR POSSIBLE LOTS WAS ALSO CONDUCTED. THE COMPLAINT DEVICES WERE NOT RETURNED TO COOK FOR INVESTIGATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THE LOT NUMBER WAS NOT PROVIDED TO COOK; HOWEVER, A SEARCH OF SALES IDENTIFIED FOUR POSSIBLE LOTS. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY FOUND NO RELEVANT DISCREPANCIES OR ADDITIONAL COMPLAINTS ON ANY OF THE POSSIBLE LOTS. THE PRODUCT IFU CAUTIONS THE USER NOT TO ATTEMPT INSERTION OR WITHDRAWAL OF THE WIRE IF RESISTANCE IS FELT. THE IFU CAUTIONS ¿WITHDRAW OR MANIPULATION OF THE DISTAL SPRING COIL PORTION OF THE MANDRIL WIRE GUIDE THROUGH A NEEDLE TIP MAY RESULT IN BREAKAGE.¿ 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, DHR, AND IFU SUGGESTS THAT THERE IS EVIDENCE THE DEVICES WERE MANUFACTURED TO SPECIFICATION. BASED ON THE LIMITED INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A COMPONENT FAILURE, UNRELATED TO DESIGN OR MANUFACTURING, CONTRIBUTED TO THIS EVENT. 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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.

    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.

    Description of Event or Problem · 0

    AS REPORTED, DURING AN UNKNOWN PROCEDURE, TWO UNSPECIFIED COOK "PEDAL KIT WIRES" BROKE. AN ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE THE SECOND BROKEN WIRE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222258 DYB INTRODUCER, CATHETER DYB COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention