BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    MDR report key: 15555158 · Received October 6, 2022

    Report

    Report Number
    1820334-2022-01599
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Date of Event
    September 22, 2022
    Report Date
    January 10, 2023
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002304925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. PMA/510(K) NUMBER = K130766. 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, UNAVAILABLE, OR UNCHANGED. SUMMARY OF EVENT: AS REPORTED, WHILE RESTOCKING INVENTORY, FOREIGN MATTER WAS NOTED INSIDE A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE'S PACKAGE. THIS WAS NOT NOTED DURING A PROCEDURE; THEREFORE, NO PATIENTS WERE INVOLVED. 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 WAS ALSO CONDUCTED. THE COMPLAINANT RETURNED FIVE ROADRUNNER HYDROPHILIC WIRE GUIDES TO COOK FOR INVESTIGATION. A PHYSICAL EXAMINATION OF THE RETURNED DEVICES REVEALED THAT ONLY ONE OF THE FIVE PACKAGES CONTAINED FOREIGN MATTER IN THE FORM OF A SMALL BLACK PARTICLE ABOVE THE BOTTOM OF THE SEAL. COOK REVIEWED THE PRODUCT LABELING. THE PRODUCT BOX LABEL, POUCH LABEL, AND IFU DO NOT CONTAIN ANY RELEVANT INFORMATION RELATED TO THIS FAILURE. COOK ALSO REVIEWED THE DEVICE HISTORY RECORD (DHR). THE DHR FOR THE COMPLAINT DEVICE RECORDS ONE RELEVANT NONCONFORMANCE FOR TWO DEVICES THAT HAD FOREIGN MATTER IN THE SEAL OF THE PACKAGE; HOWEVER, BOTH PRODUCTS WERE REWORKED AND INSPECTED 100%. A DATABASE SEARCH FOR COMPLAINTS REPORTED ON THE COMPLAINT LOT REVEALED NO ADDITIONAL COMPLAINTS AT THIS TIME. THEREFORE, COOK DETERMINED THAT NO NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. A REVIEW OF RELEVANT MANUFACTURING AND QUALITY CONTROL DOCUMENTS WERE CONDUCTED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION OBTAINED UPON REVIEW OF THE COMPLAINT DEVICE AND THE DMR PROVIDES EVIDENCE THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. BASED UPON THE AVAILABLE INFORMATION AND RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A MANUFACTURING/QUALITY CONTROL DEFICIENCY WAS THE CAUSE OF THIS INCIDENT. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION IS 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, WHILE RESTOCKING INVENTORY, FOREIGN MATTER WAS NOTED INSIDE A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE'S PACKAGE. THIS WAS NOT NOTED DURING A PROCEDURE; THEREFORE, NO PATIENTS WERE INVOLVED.

    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
    1417815 ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G30492 14624292 00827002304925

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown