BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COPE NITINOL MANDRIL WIRE GUIDE

    MDR report key: 21143386 · Received January 13, 2025

    Report

    Report Number
    1820334-2025-00050
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    January 8, 2025
    Report Date
    August 4, 2025
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002084278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E3: OCCUPATION: INVENTORY MANAGER. G4: PMA/510(K) #: K171997. 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. INVESTIGATION ¿ EVALUATION IT WAS REPORTED THAT A COPE NITINOL MANDRIL WIRE GUIDE UNRAVELED DURING ACCESS IN AN UNKNOWN PROCEDURE FOR AN UNKNOWN PATIENT. A NEW LIKE-DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. IT WAS CONFIRMED BY THE USER THAT THE WIRE GUIDE DID NOT SEPARATE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DRAWING, DEVICE HISTORY RECORD, QUALITY CONTROL, SPECIFICATIONS, AS WELL AS A VISUAL INSPECTION OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE USED DEVICE WAS RETURNED. COIL ELONGATION WAS NOTED THROUGHOUT THE ENTIRE LENGTH. DISTAL SOLDER CONNECTION WAS NOT PRESENT. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. A REVIEW OF THE DHR FOR THE REPORTED COMPLAINT DEVICE REVEALED NO RECORDED NON-CONFORMANCES RELEVANT TO THE FAILURE MODE. A COMPLAINT HISTORY SEARCH DID NOT IDENTIFY ANY OTHER EVENTS ASSOCIATED WITH THE REPORTED DEVICE LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCTS EXISTS EITHER IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: WARNINGS: "AVOID MANIPULATING OR WITHDRAWING THE WIRE GUIDE BACK THROUGH A METAL NEEDLE OR CANNULA. A SHARP EDGE MAY SCRAPE OR SHEAR MATERIAL FROM THE WIRE GUIDE". PRECAUTIONS: "WHEN YOU USE THE WIRE GUIDE WITH ANOTHER DEVICE, CONSIDER THE END-HOLE SIZE AND THE LENGTH OF THE DEVICE IN ORDER TO ENSURE A PROPER FIT BETWEEN THE WIRE GUIDE AND THE DEVICE". HOW SUPPLIED: "UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED". THE WIRE GUIDE HOLDER IS SUPPLIED WITH AN L_SCOR LABEL ATTACHED INDICATING TO NOT WITHDRAW OR MANIPULATE THE WIRE GUIDE THROUGH A NEEDLE. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO MANUFACTURING DEFICIENCIES CONTRIBUTED TO THE REPORTED EVENT. IT IS POSSIBLE THAT IF THE PATIENT HAD A TORTUOUS ANATOMY, WHICH COULD HAVE LED TO THIS EVENT AS THE WIRE GUIDE IS A DELICATE INSTRUMENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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

    IT WAS REPORTED THAT A COPE NITINOL MANDRIL WIRE GUIDE UNRAVELED DURING ACCESS IN AN UNKNOWN PROCEDURE FOR AN UNKNOWN PATIENT. A NEW LIKE-DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. IT WAS CONFIRMED BY THE USER THAT THE WIRE GUIDE DID NOT SEPARATE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    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
    2178542 COPE NITINOL MANDRIL WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G08427 16086826 00827002084278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown