BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE

    MDR report key: 17318213 · Received July 13, 2023

    Report

    Report Number
    1820334-2023-00894
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Report Date
    October 24, 2023
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002096097
    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). POSTAL CODE: (B)(6). PHONE: (B)(6). G4: PMA/510(K) NUMBER: (B)(6). G4: PMA/510(K) NUMBER: K182985. H3: DEVICE EVALUATED BY MFG: OTHER (81) - DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, UPON ARRIVAL TO A DISTRIBUTION FACILITY, A ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE'S PACKAGE WAS FOUND TO BE PERFORATED. A PHOTO PROVIDED BY THE CUSTOMER SHOWS A SMALL HOLE/TEAR IN THE FRONT OF THE PACKAGE. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE UNUSED COMPLAINT DEVICE WAS ALSO CONDUCTED. THE UNUSED COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. A TEAR WAS NOTED IN THE PACKAGE. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER REPORTED 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.¿ 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. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A DEFINITIVE CAUSE FOR THIS EVENT CANNOT BE ESTABLISHED. 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, UPON ARRIVAL TO A DISTRIBUTION FACILITY, A ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE'S PACKAGE WAS FOUND TO BE PERFORATED. A PHOTO PROVIDED BY THE CUSTOMER SHOWS A SMALL HOLE/TEAR IN THE FRONT OF THE PACKAGE.

    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
    312858 ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G09609 15254344 00827002096097

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown