BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE

    MDR report key: 11711484 · Received April 22, 2021

    Report

    Report Number
    1820334-2021-01193
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    April 9, 2021
    Report Date
    September 3, 2021
    Manufacturer
    COOK INC
    Product Code
    DXQ
    UDI-DI
    00827002305069
    PMA / PMN Number
    K130766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SUMMARY: AS REPORTED, WHILE USING A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE AND PERFORMING A LOWER LEFT LIMB VEIN THROMBOSIS ASPIRATION THROUGH THE LEFT ILIAC VEIN, THE WIRE GUIDE SEPARATED. THE CATHETER AND WIRE GUIDE WERE TURNED OVER FROM THE RIGHT ILIAC VEIN TO THE LEFT SIDE, AND THE WIRE GUIDE WAS ALREADY ON THE LEFT SIDE. WHEN THE USER OPERATED THE WIRE GUIDE, IT WAS FOUND THAT THE END TIP OF THE WIRE GUIDE WAS NOT MOVED (THE GUIDE WIRE WAS DISCONNECTED INSIDE THE FRONT PART OF THE CATHETER). THEN THE USER REMOVED THE WIRE GUIDE AND CATHETER TOGETHER FROM THE PATIENT AND REPLACED THE WIRE GUIDE 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. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION - EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES AND A VISUAL INSPECTION OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. ONE HPWAS-35-260 WAS RETURNED FOR INVESTIGATION SEPARATED INTO TWO SECTIONS MEASURING 10.5CM AND 248.5CM. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE RECORDED, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE HISTORY RECORD REVIEW PROVIDES OBJECTIVE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE 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 DEVICE IS PROVIDED WITH INSTRUCTIONS FOR USE WHICH STATE, ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT A COMPONENT FAILURE CONTRIBUTED TO THIS INCIDENT. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAS NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. 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

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

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER NAME AND ADDRESS: (B)(6). 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

    AS REPORTED, WHILE USING A ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE AND PERFORMING A LOWER LEFT LIMB VEIN THROMBOSIS ASPIRATION THROUGH THE LEFT ILIAC VEIN, THE WIRE GUIDE SEPARATED. THE CATHETER AND WIRE GUIDE WERE TURNED OVER FROM THE RIGHT ILIAC VEIN TO THE LEFT SIDE, AND THE WIRE GUIDE WAS ALREADY ON THE LEFT SIDE. WHEN THE USER OPERATED THE WIRE GUIDE, IT WAS FOUND THAT THE END TIP OF THE WIRE GUIDE WAS NOT MOVED (THE GUIDE WIRE WAS DISCONNECTED INSIDE THE FRONT PART OF THE CATHETER). THEN THE USER REMOVED THE WIRE GUIDE AND CATHETER TOGETHER FROM THE PATIENT AND REPLACED THE WIRE GUIDE TO COMPLETED 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. 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
    607353 ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE DQX WIRE, GUIDE, CATHETER DXQ COOK INC G30506 8934985 00827002305069

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR HNB5.0-38-100-P-NS-DAV| KCFW-10.0-38-80-RB