BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE

    MDR report key: 13367763 · Received January 27, 2022

    Report

    Report Number
    1820334-2022-00126
    Event Type
    Malfunction
    Date Received
    January 27, 2022
    Report Date
    April 27, 2022
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002096073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OCCUPATION = ACCESS COORDINATOR. 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.

    Additional Manufacturer Narrative · 0

    SUMMARY OF EVENT: AS REPORTED, TWENTY-FIVE ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDES WERE STICKY AND DIFFICULT TO ADVANCE. THIS OCCURRED DURING FISTULAGRAMS, THROMBECTOMIES, AND DURING CATHETER INSERTIONS. THERE HAS BEEN NO REPORT THAT ANY PATIENT REQUIRED ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS FROM THESE EVENTS. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. 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 ¿FLUSH THE WIRE GUIDE HOLDER BY ATTACHING OR PRESSING A SYRINGE WITH SALINE, HEPARINIZED SALINE SOLUTION, OR STERILE WATER TO THE FITTING OR OPENING OF THE WIRE GUIDE HOLDER. INJECT ENOUGH SOLUTION TO WET THE WIRE SURFACE ENTIRELY. THIS WILL ACTIVATE THE AQ COATING.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, AND IFU 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 COMPONENT FAILURE UNRELATED TO MANUFACTURING CONTRIBUTED TO THIS INCIDENT. 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, TWENTY-FIVE ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDES WERE STICKY AND DIFFICULT TO ADVANCE. THIS OCCURRED DURING FISTULAGRAMS, THROMBECTOMIES, AND DURING CATHETER INSERTIONS. THERE HAS BEEN NO REPORT THAT ANY PATIENT REQUIRED ADDITIONAL PROCEDURES OR EXPERIENCED ANY ADVERSE EFFECTS FROM THESE EVENTS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326920 ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G09607 14276964 00827002096073

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown