BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE

    MDR report key: 12860476 · Received November 23, 2021

    Report

    Report Number
    1820334-2021-02564
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    November 11, 2021
    Report Date
    March 21, 2022
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002076402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NAME AND ADDRESS: POSTAL CODE: (B)(6) OCCUPATION: OTHER NON-HEALTHCARE PROFESSIONAL: CUSTOMER SERVICE. PMA/510K # K183467. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, DURING A SUPERFICIAL FEMORAL ARTERY (SFA) OCCLUSION PROCEDURE A ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE UNRAVELED WHILE BEING REMOVED. THE WIRE GUIDE HAD BEEN ADVANCED THROUGH A CXI SUPPORT CATHETER, WHILE THE USER WAS ATTEMPTING TO CROSS THE SFA. THE USER ATTEMPTED TO REMOVE THE WIRE GUIDE WHEN IT BEGAN TO UNRAVEL. ANOTHER ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROLS WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS ALSO CONDUCTED. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. THE DISTAL TIP WAS UNRAVELED AND THE WELD BALL WAS PRESENT. COOK COMPLETED A REVIEW OF THE DEVICE HISTORY RECORD (DHR). THE DHR FOUND 1 RELEVANT NON-CONFORMANCE ON 3 DEVICES. ALTHOUGH THESE NON-CONFORMANCES ARE RELEVANT TO THE REPORTED FAILURE MODE, ALL NON-CONFORMING PRODUCT WAS SCRAPPED AND THERE ARE 100% INSPECTIONS TO CAPTURE THIS NON-CONFORMANCE. A DATABASE SEARCH FOR COMPLAINTS ON THE REPORTED LOT FOUND NO ADDITIONAL COMPLAINTS REPORTED FROM THE FIELD. BECAUSE 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 NON-CONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THE REPORTED EVENT. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: HOW SUPPLIED ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ THERE IS A POSSIBILITY THE ATTEMPT TO CROSS THE STENOSIS ASSISTED IN THE FAILURE. COOK HAS CONCLUDED THAT PATIENT ANATOMY CONTRIBUTED TO THIS INCIDENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. 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

    AS REPORTED, DURING A SUPERFICIAL FEMORAL ARTERY (SFA) OCCLUSION PROCEDURE A ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE UNRAVELED WHILE BEING REMOVED. THE WIRE GUIDE HAD BEEN ADVANCED THROUGH A CXI SUPPORT CATHETER, WHILE THE USER WAS ATTEMPTING TO CROSS THE SFA. THE USER ATTEMPTED TO REMOVE THE WIRE GUIDE WHEN IT BEGAN TO UNRAVEL. ANOTHER ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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
    1757000 ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G07640 13680775 00827002076402

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male COOK MEDICAL CXI SUPPORT CATHETER