BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COPE MANDRIL WIRE GUIDE

    MDR report key: 12447321 · Received September 9, 2021

    Report

    Report Number
    1820334-2021-02120
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Report Date
    January 12, 2022
    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 UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. ON 16AUG2021, LHSC UNIVERSITY CAMPUS INFORMED COOK OF AN INCIDENT INVOLVING A COPE MANDRIL WIRE GUIDE (RPN: PMG-18SP-60-COPE) FROM AN UNKNOWN LOT. THE TIP OF THE WIRE GUIDE BROKE OFF IN A PICC LINE PRIOR TO INSERTION. NO ADDITIONAL HARM WAS REPORTED. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. A DEVICE MASTER RECORD (DMR) REVIEW WAS PERFORMED, AND DEVICE DRAWINGS, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES ASSOCIATED WITH THE COMPLAINT WERE IDENTIFIED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DEVICE¿S DESIGN HISTORY FILES (DHF) WERE REVIEWED, AND THE RISKS ASSOCIATED WITH THESE DEVICES ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. CONTROLS IN PLACE TO PREVENT THIS FAILURE MODE INCLUDE WELDING WITH ATRAUMATIC FINISH AND SURFACE CHARACTERISTICS 100% INSPECTED AND VERIFIED PRIOR TO PACKAGING. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER FOR THE COMPLAINT DEVICES. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND FOUND THAT THIS CUSTOMER HAS ORDERED FROM FOUR DIFFERENT LOT NUMBERS SINCE 01JAN2018. A DATABASE SEARCH FOR COMPLAINT ON THESE LOTS FOUND NO ADDITIONAL COMPLAINTS REPORTED FROM THE FIELD. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. FROM THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHF, POSSIBLE DEVICE LOT ANALYSIS, AND IFU, COOK CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THE PRODUCT IFU, [T_MWG_REV0] ¿MANDRIL WIRE GUIDES,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS: ¿THIS PRODUCT IS A DELICATE INSTRUMENT. AVOID FORCEFUL ANGULATION. 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.¿ 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, THE COMPLAINT DEVICE NOT BEING RETURNED, AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES CONTRIBUTED TO THIS INCIDENT. IT IS POSSIBLE THAT THE TECHNIQUE OF WIRE GUIDE MANIPULATION CONTRIBUTED TO THIS FAILURE, BUT THIS CANNOT BE DEFINITIVELY CONFIRMED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. 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

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EVENT OCCURRED EARLIER IN THE WEEK OF (B)(6) 2021. CUSTOMER (PERSON): POSTAL CODE: (B)(6). OCCUPATION: COORDINATOR. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A COPE MANDRIL WIRE GUIDE BROKE OFF IN A PICC LINE PRIOR TO A PERMACATH INSERTION IN AN UNKNOWN PATIENT. THE WIRE WAS NOT WITHDRAWN THROUGH THE NEEDLE AND NO RESISTANCE WAS FELT WHEN REMOVING THE WIRE. AT THIS TIME, NO HARM TO THE PATIENT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342641 COPE MANDRIL WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown