BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE

    MDR report key: 4961020 · Received July 31, 2015

    Report

    Report Number
    1820334-2015-00482
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 15, 2015
    Manufacturer
    COOK INC
    Product Code
    DXQ
    PMA / PMN Number
    K920824
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION - EVALUATION: DURING THE COURSE OF INVESTIGATION, A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), QUALITY CONTROL (QC), SPECIFICATIONS, AND A VISUAL INSPECTION OF THE RETURNED PRODUCT WAS CONDUCTED. THE VISUAL INSPECTION NOTED THE FOLLOWING: PRODUCT WAS IN A USED CONDITION. WIRE GUIDE MEASURED APPROXIMATELY 297.9 CM. SEPARATE COIL WIRE, WHICH WAS STRETCHED, MEASURED APPROXIMATELY 13.4 CM. A REVIEW OF THE LOT RECORDS WERE REVIEWED. NO ISSUES CONCERNING THE QUALITY OF THE PRODUCT RELATIVE TO THIS INVESTIGATION WERE NOTED. THE MANUFACTURING AND QC DEPARTMENTS PERFORM A 100% INSPECTION, VERIFYING EACH DEVICE IS FREE FROM BENDS, KINKS, HAS ADEQUATE JOINT STRENGTH, CORRECT OUTSIDE DIMENSION AND OTHER SURFACE IMPERFECTIONS DURING THE MANUFACTURING PROCESS AND AGAIN, PRIOR TO TRANSPORT. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE OF THIS ISSUE COULD NOT BE DETERMINED. HOWEVER, WE WILL CONTINUE TO MONITOR THIS DEVICE. PER THE RISK ASSESSMENT (RA); NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    DURING A SUPERIOR FEMORAL ARTERY INTERVENTION PROCEDURE ON A (B)(6) MALE PATIENT, THE ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE WAS BEING UTILIZED. THE JET STREAM WAS USED AND IT NEVER GOT ANYWHERE CLOSE TO THE TIP OF THE WIRE. THE PROCEDURE WAS COMPLETED AND A FINAL ANGIOGRAM OF THE FOOT WAS DONE. IT WAS THEN NOTICED THAT A 10CM PIECE OF THE WIRE SEPARATED AND REMAINED IN THE FOOT. THE REMOVED DEVICE WAS EXAMINED AND IT WAS NOTED THAT THE WIRE HAD BROKEN OFF. THE SEPARATED WIRE WAS SNARED AND IT AGAIN BROKE AT THE POINT OF WHERE THEY HAD SNARED IT. THEY DID REMOVE THE 2 SEPARATED PIECES AND NO HARM WAS DONE TO THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    DURING A SUPERIOR FEMORAL ARTERY INTERVENTION PROCEDURE ON A (B)(6) MALE PT, THE ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE WAS BEING UTILIZED. THE JET STREAM WAS USED AND IT NEVER GOT ANYWHERE CLOSE TO THE TIP OF THE WIRE. THE PROCEDURE WAS COMPLETED AND A FINAL ANGIOGRAM OF THE FOOT WAS DONE. IT WAS THEN NOTICED THAT A 10 CM PIECE OF THE WIRE SEPARATED AND REMAINED IN THE FOOT. THE REMOVED DEVICE WAS EXAMINED AND IT WAS NOTED THAT THE WIRE HAD BROKEN OFF. THE SEPARATED WIRE WAS SNARED AND IT AGAIN BROKE AT THE POINT OF WHERE THEY HAD SNARED IT. THEY DID REMOVE THE 2 SEPARATED PIECES AND NO HARM WAS DONE TO THE PT. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499095 ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE DQX WIRE, GUIDE, CATHETER DXQ COOK INC N/A 5798726

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention