BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE

    MDR report key: 15751254 · Received November 8, 2022

    Report

    Report Number
    1820334-2022-01705
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Date of Event
    October 25, 2022
    Report Date
    February 16, 2023
    Manufacturer
    COOK INC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. OCCUPATION : DISTRIBUTOR. PMA/510(K) #: 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. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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, AN UNIDENTIFIED PARTICLE WAS FOUND INSIDE THE PACKAGING OF A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE. THIS WAS OBSERVED WITHIN A DISTRIBUTION FACILITY; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. CORRECTED INFORMATION: H6 (ANNEX A) INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION; HOWEVER, A PHOTO WAS PROVIDED BY THE CUSTOMER, SHOWING A METAL-LIKE PIECE OF FOREIGN MATTER IN THE SEALED PACKAGE. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD NOTED ONE RELEVANT NON-CONFORMANCE; HOWEVER, AFFECTED PRODUCT WAS REWORKED AND 100% REINSPECTED. ALTHOUGH THE COMPLAINT DEVICE IS NONCONFORMING, THERE IS NO EVIDENCE TO SUGGEST THAT ADDITIONAL NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. THE PRODUCT IFU STATES ¿DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE.¿ THE INFORMATION PROVIDED UPON REVIEW OF PROVIDED IMAGES CONFIRMED THAT THE COMPLAINT DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. 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 MANUFACTURING/QUALITY CONTROL DEFICIENCY 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.

    Description of Event or Problem · 0

    AS REPORTED, AN UNIDENTIFIED PARTICLE WAS FOUND INSIDE THE PACKAGING OF A ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE. THIS WAS OBSERVED WITHIN A DISTRIBUTION FACILITY; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    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
    2548382 ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC N/A 14897749

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown