BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COPE MANDRIL WIRE GUIDE

    MDR report key: 11870888 · Received May 24, 2021

    Report

    Report Number
    1820334-2021-01387
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Report Date
    January 26, 2022
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002051836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIPTION OF EVENT: IT WAS REPORTED AN UNKNOWN PATIENT WITH TORTUOUS ANATOMY REQUIRED A COPE MANDRIL WIRE GUIDE FOR AN ATHERECTOMY. DURING THE PROCEDURE IN (B)(6) 2019, THE USER REMOVED THE WIRE GUIDE THROUGH A CATHETER AND DISCOVERED THE END OF THE WIRE GUIDE HAD "CAME UNDONE". THE USER DID NOT OBSERVE KINKING OF THE WIRE GUIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNKNOWN WIRE. INVESTIGATION ¿ EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, INTERVIEW OF PERSONNEL, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA. THE CUSTOMER RETURNED PMG-18SP-60-COPE TO COOK FOR INVESTIGATION. PHYSICAL EXAMINATION OF THE RETURNED DEVICE SHOWED: VISUAL INSPECTION RESULTS, ONE USED DEVICE RECEIVED. DISTAL POSITION OF COIL EXHIBITED COIL ELONGATION WITH WELD BALL MISSING. THERE IS NO EVIDENCE FROM DEVICE FAILURE ANALYSIS THAT THE COMPLAINT WAS MANUFACTURED OUT OF SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: 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. ALTERING THE TIP¿S CONFIGURATION OR CURVE MANUALLY MAY DAMAGE THE WIRE GUIDE. THERE IS A LABEL ATTACHED TO THE WIRE GUIDE HOLDER/HOOP WITH AN IMAGE WARNING THE USER NOT TO REMOVE THE WIRE GUIDE THROUGH THE NEEDLE. ¿HOW SUPPLIED¿ UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. COOK HAS CONCLUDED A COMPONENT FAILURE CONTRIBUTED TO THIS FAILURE MODE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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.

    Description of Event or Problem · 0

    THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT SINCE THE LAST MEDWATCH REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED SOMETIME IN (B)(6) 2019. CATH LAB DIRECTOR. K171997. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED AN UNKNOWN PATIENT WITH TORTUOUS ANATOMY REQUIRED A COPE MANDRIL WIRE GUIDE FOR AN ATHERECTOMY. DURING THE PROCEDURE IN (B)(6) 2019, THE USER REMOVED THE WIRE GUIDE THROUGH A CATHETER AND DISCOVERED THE END OF THE WIRE GUIDE HAD "CAME UNDONE". THE USER DID NOT OBSERVE KINKING OF THE WIRE GUIDE. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNKNOWN WIRE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768814 COPE MANDRIL WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G05183 7310880 00827002051836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CATHETER- MANUFACTURER UNKNOWN| CATHETER- MANUFACTURER UNKNOWN