BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE

    MDR report key: 17450592 · Received August 3, 2023

    Report

    Report Number
    1820334-2023-01012
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 17, 2023
    Report Date
    November 7, 2023
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002068667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E1: NAME AND ADDRESS - POSTAL CODE: 1164. (B)(6). E3: INITIAL REPORTER OCCUPATION - REGULATOR AFFAIRS CHIEF. G4: 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, UNAVAILABLE, OR UNCHANGED. SUMMARY OF EVENT: AS REPORTED, FOREIGN MATTER WAS FOUND IN THE PACKAGING OF A ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE AT THE DISTRIBUTION FACILITY. THERE WAS NO PATIENT/PROCEDURE INVOLVEMENT. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL PROCEDURES, AND A VISUAL EXAMINATION WERE CONDUCTED DURING THE INVESTIGATION. THE CUSTOMER RETURNED THE SEALED DEVICE TO COOK FOR INVESTIGATION. A SMALL PARTICLE WAS NOTED SEALED INSIDE THE POUCH. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER RELATED COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT IFU PROVIDED THE FOLLOWING INFORMATION: HOW SUPPLIED: ¿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.¿ BASED ON THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU, AND INSPECTION OF THE RETURNED DEVICE, COOK HAS CONCLUDED THAT THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATION. AT THIS TIME, COOK CONCLUDED THAT NO ADDITIONAL NONCONFORMING PRODUCT FROM THIS LOT EXISTS 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 AVAILABLE INFORMATION AND RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE CAUSE OF THIS FAILURE IS A QUALITY CONTROL DEFICIENCY. 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, FOREIGN MATTER WAS FOUND IN THE PACKAGING OF A ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE AT THE DISTRIBUTION FACILITY. THERE WAS NO PATIENT/PROCEDURE 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
    325070 ROADRUNNER THE FIRM LT HYDROPHILIC WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC 15439969 00827002068667

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown