BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COPE NITINOL MANDRIL WIRE GUIDE

    MDR report key: 19893001 · Received August 2, 2024

    Report

    Report Number
    1820334-2024-01038
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    May 31, 2024
    Report Date
    October 28, 2024
    Manufacturer
    COOK INC
    Product Code
    DQX
    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. 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

    INVESTIGATION ¿ EVALUATION: IT WAS REPORTED THAT THE COPE NITINOL MANDRIL WIRE GUIDE WAS FOUND TO BE DEFECTIVE AND FRAYED DURING THE INSTALLATION OF PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE, DESPITE BEING UNUSED. THIS RESULTED IN OPENING AND UTILIZATION OF A NEW WIRE GUIDE. IT WAS CONFIRMED THAT THE WIRE WAS UNALTERED PRIOR TO USE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL PROCEDURES AND INSTRUCTIONS FOR USE (IFU), AS WELL AS VISUAL INSPECTION OF THE RETURNED PRODUCT, WERE CONDUCTED DURING THE INVESTIGATION. ONE PRIOR TO USE WIRE GUIDE WAS RECEIVED FOR EVALUATION. OFFSET COILS WERE NOTED 4MM FROM THE DISTAL TIP. THE DEVICE BEGAN TO UNRAVEL AT THE SOLDER JOINT. 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 DEVICE HISTORY RECORD (DHR) FOR THE DEVICE FOUND TWO POSSIBLE RELEVANT NONCONFORMANCE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE, IN WHICH ALL THE NONCONFORMING DEVICES WERE SCRAPPED. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THE FINAL PRODUCT LOT NUMBER. COOK ALSO REVIEWED PRODUCT LABELING: THIS PRODUCT IS SUPPLIED WITH AN INSTRUCTIONS FOR USE (IFU) PAMPHLET, T_MWG_REV0. HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. EVIDENCE GATHERED UPON REVIEW OF THE DMR, IFU, DHR AND RETURNED DEVICE SUGGESTS THAT THE DEVICE WAS NOT MANUFACTURED OUT OF SPECIFICATION, AND THAT THERE ARE NO NONCONFORMING DEVICES IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT THE DISTAL TIP DAMAGE MOST LIKELY OCCURRED DURING THE SHIPPING PROCESS, POSSIBLY DUE TO ROUGH TRANSPORT. BASED ON THE DISTAL TIP DAMAGE OF THE COILS, IT IS FEASIBLE TO CONCLUDE THE DISTAL TIP SOLDER CONNECTION SEPARATED, RESULTING IN COIL ELONGATION AT THE PROXIMAL END NEAR THE ANCHOR SOLDER WHEN THE USER ATTEMPTED TO REMOVE THE MANDRIL GUIDE FROM THE SINGLE LOOP HOLDER. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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 THE COPE NITINOL MANDRIL WIRE GUIDE WAS FOUND TO BE DEFECTIVE AND FRAYED DURING THE INSTALLATION OF PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE, DESPITE BEING UNUSED. THIS RESULTED IN OPENING AND UTILIZATION OF A NEW WIRE GUIDE. IT WAS CONFIRMED THAT THE WIRE WAS UNALTERED PRIOR TO USE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE.

    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
    1216385 COPE NITINOL MANDRIL WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G08687 15720515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown