BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE

    MDR report key: 19364578 · Received May 21, 2024

    Report

    Report Number
    1820334-2024-00702
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    October 13, 2023
    Report Date
    August 12, 2024
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002091054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: CUSTOMER NAME AND ADDRESS = (B)(6). E3: OCCUPATION = REGULATORY AFFAIRS CHIEF. G4: PMA/510(K) NUMBER = K182985. 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 BY A DISTRIBUTOR, THE PACKAGING OF A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE WAS "BROKEN". THERE WAS NO PATIENT INVOLVEMENT. 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. A VISUAL INSPECTION OF THE UNUSED COMPLAINT DEVICE WAS ALSO CONDUCTED. THE SEALED/UNUSED COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. A PUNCTURE/HOLE WAS NOTED IN THE CLEAR PACKAGING, JUST BELOW THE LABEL. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND ONE RELEVANT NON-CONFORMANCE ON THREE DEVICES; HOWEVER, ALL AFFECTED PRODUCT WAS RE-WORKED PRIOR TO RELEASE. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELEVANT COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT IFU STATES ¿SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED AND UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ 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, IFU, AND INVESTIGATION OF THE RETURNED DEVICE SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. ALTHOUGH ONE RELEVANT NON-CONFORMANCE WAS NOTED ON THE LOT, ALL NON-CONFORMING PRODUCT WAS RE-WORKED PRIOR TO RELEASE, THERE ARE 100% INSPECTIONS IN PLACE TO CAPTURE THIS NON-CONFORMANCE, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT-RELATED RELEVANT COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. THEREFORE, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT ADDITIONAL NON-CONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A DEFINITIVE CAUSE FOR THIS EVENT COULD NOT BE ESTABLISHED AT THIS TIME. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THERE IS CURRENTLY A CAPA INVESTIGATION OPEN TO INVESTIGATE THIS PRODUCT FAILURE. 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 BY A DISTRIBUTOR, THE PACKAGING OF A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE WAS "BROKEN". THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664996 ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G09105 15581827 00827002091054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown