BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE

    MDR report key: 7221917 · Received January 26, 2018

    Report

    Report Number
    1820334-2018-00193
    Event Type
    Injury
    Date Received
    January 26, 2018
    Report Date
    April 23, 2018
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002075184
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, SPECIFICATIONS, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT A SECTION OF WIRE HAD UNRAVELED AT THE DISTAL END. A SEGMENT OF MANDRIL WIRE WAS NOTED STICKING OUT OF THE JACKET APPROXIMATELY 3.3 CM PROXIMAL OF THE PROXIMAL END OF THE UNRAVELED SECTION. THE PORTION OF THE WIRE THAT HAD NOT UNRAVELED MEASURED 181.5 CM IN LENGTH. NO SOLDER JOINT WAS PRESENT AT THE DISTAL END OF THE WIRE. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. 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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED.

    Additional Manufacturer Narrative · 1

    PRODUCT CODE = DQX. PMA/510(K) NUMBER = K901899. (B)(4). 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 DURING ENDOVASCULAR SURGERY, THE ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE CAME OUT OF THE LUMEN OF ANOTHER MANUFACTURER'S 5 FR CATHETER. WHEN THE PHYSICIAN TRIED TO REPOSITION THE WIRE GUIDE, THE TIP WAS OBSERVED TO BE BROKEN. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY AS THE LESION COULD NOT BE RE-CANALIZED AND THE BROKEN TIP PORTION REMAINED INSIDE OF THE PATIENT'S ANATOMY. A BY-PASS WAS PERFORMED AND THE TIP PORTION WAS UNABLE TO BE RETRIEVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65350 ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC 00827002075184

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention