BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COPE NITINOL MANDRIL WIRE GUIDE

    MDR report key: 8139150 · Received December 6, 2018

    Report

    Report Number
    1820334-2018-03480
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Date of Event
    October 12, 2018
    Report Date
    January 29, 2019
    Manufacturer
    COOK INC
    Product Code
    DXQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. PRODUCT CODE: CORRECTED FROM DXQ TO DQX. INVESTIGATION ¿ EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DRAWING, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE WAS 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. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH SPECIFIES THAT THE WIRE GUIDE SHOULD NOT BE WITHDRAWN THROUGH THE NEEDLE. THE INITIAL REPORTER HAD CONFIRMED THAT THIS CONTRAINDICATED ACTION WAS PERFORMED. WITHDRAWING A WIRE GUIDE THROUGH THE NEEDLE HAS BEEN PREVIOUSLY OBSERVED TO CAUSE OR CONTRIBUTE TO SEPARATION. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE WAS TRACED TO THE USER. PER THE QUALITY ENGINEERING 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. 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

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

    Additional Manufacturer Narrative · 1

    OCCUPATION: REGISTERED CARDIOVASCULAR INVASIVE SPECIALIST (RCIS). PMA/510(K) #: PREAMENDMENT. 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 A COPE NITINOL MANDRIL WIRE GUIDE WAS PLACED INTO THE BODY OF A PATIENT DURING AN UNKNOWN PROCEDURE. AFTER AN UNSPECIFIED AMOUNT OF TIME, AS THE WIRE WAS BEING WITHDRAWN FROM THE PATIENT THROUGH THE NEEDLE, IT BEGAN TO UNRAVEL. THE DEVICE WAS ABLE TO BE REMOVED WITHIN THE NEEDLE. AS REPORTED, NO ADVERSE EFFECTS WERE EXPERIENCED BY THE PATIENT DUE TO THIS OCCURRENCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS INTENDED. PER THE CUSTOMER, FURTHER DEVICE INFORMATION IS UNAVAILABLE. ADDITIONAL EVENT DETAILS SUCH AS TYPE OF PROCEDURE HAVE BEEN REQUESTED BUT ARE UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978782 COPE NITINOL MANDRIL WIRE GUIDE DQX WIRE, GUIDE, CATHETER DXQ COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1