BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 13545733 · Received February 16, 2022

    Report

    Report Number
    9681834-2022-00015
    Event Type
    Injury
    Date Received
    February 16, 2022
    Date of Event
    March 11, 2021
    Report Date
    February 16, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXPIRATION DATE UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. HEALTH PROFESSIONAL: UNKNOWN. OCCUPATION: UNKNOWN. PMA/510(K): K863138, K923607, K926214. DEVICE MANUFACTURER DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. INVESTIGATION FINDINGS BASED UPON EVALUATION OF USER FACILITY INFORMATION AND THE VISUAL INSPECTION FROM THE PHOTO; BASED UPON NO DEVICE BEING RETURNED FOR EVALUATION. THE ACTUAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, A PICTURE WAS RECEIVED. THE PICTURE PROVIDED FOR ANALYSIS SHOWED THAT A PART OF THE OUTER LAYER HAD BEEN PEELED OFF. REVIEW OF RELEVANT RECORD COULD NOT BE PERFORMED SINCE THE INVOLVED LOT NUMBER WAS UNKNOWN. BASED ON OUR PAST FINDINGS, IT IS KNOWN THAT THE OUTER LAYER MAY BE PEELED OFF WHEN RADIFOCUS GUIDEWIRE M IS USED IN COMBINATION WITH A METAL NEEDLE. BASED ON THE DESCRIPTION OF THE COMPLAINT EVENT, IT WAS PRESUMED THAT THE OUTER LAYER MIGHT HAVE COME INTO CONTACT WITH THE EDGE OF THE METAL NEEDLE DUE TO SOME FACTORS WHEN THE ACTUAL SAMPLE WAS USED IN COMBINATION WITH THE METAL NEEDLE. HOWEVER, THE CAUSE OF THE PROBLEM COULD NOT BE CLARIFIED SINCE THE ACTUAL SAMPLE WAS NOT RETURNED FOR ANALYSIS. IFU STATES: DO NOT MANIPULATE OR WITHDRAW THE GLIDEWIRE THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR. MANIPULATION AND/OR WITHDRAWAL THROUGH A METAL ENTRY NEEDLE OR A METAL DILATOR MAY RESULT IN DESTRUCTION AND/OR SEPARATION OF THE OUTER POLYURETHANE COATING REQUIRING RETRIEVAL. A PLASTIC ENTRY NEEDLE IS RECOMMENDED WHEN USING THIS WIRE FOR INITIAL PLACEMENT. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT A PATIENT UNDERWENT CATHETER-BASED MITRAL VALVE IMPLANTATION (TMVI) ON (B)(6) 2021. IN MANY ENDOVASCULAR PROCEDURES, A 0.035 TERUMO WIRE IS USED AS A STANDARD PROCEDURE TO PROBE THE VALVE TO BE TREATED. THE INTRAOPERATIVE COURSE WAS SO FAR INCONSPICUOUS. AFTER EXTUBATING, HOWEVER, A PRONOUNCED NEUROLOGICAL CONDITION (HEMIPARESIS) WAS OBSERVED IN THE RECOVERY ROOM. THE CAUSE WAS PEELED OFF FOREIGN MATERIAL WHICH ENDED UP INTO THE VESSELS SUPPLYING THE BRAIN. HERE OBVIOUSLY PARTS OF THE PLASTIC COATING OF ONE OF THE TWO INSERTED TERUMO WIRES (J-WIRE AND STRAIGHT (J-WIRE AND STRAIGHT TIP WERE USED). THE MATERIAL WAS NOT NOTICEABLE TACTILELY OR IN THE X-RAY FLUOROSCOPY DURING THE PROCEDURE, NOR WAS ANY ABNORMALITY NOTICED ON THE PRODUCT (DUE TO THE NON-NOTICEABLE EVENT, NO SEPARATE EXAMINATION WAS PERFORMED IN THIS REGARD). THE WIRE WAS DISPOSED OF IMMEDIATELY AFTER COMPLETION OF THE OPERATION AS THE EVENT WAS NOT YET KNOWN AT THAT TIME. FORTUNATELY, THE NEUROLOGICAL FINDINGS IMMEDIATELY IMPROVED SIGNIFICANTLY. CURRENTLY (6 DAYS AFTER THE OPERATION), THE PATIENT STILL COMPLAINS OF GAIT INSTABILITY AND PROBLEMS WITH FINE MOTOR SKILLS. THE EXTENT OF PERMANENT DAMAGE CANNOT BE ASSESSED AT PRESENT. THE PROCEDURE WAS A TAVI TRANSAPICAL ACCESS. THE USER HAD TO DO A MYOCARDIAL PUNCTURE AND WANTED TO TAKE A SHEATH HOWEVER IT WAS NOT POSSIBLE, SO THE USER TOOK A STEEL NEEDLE AND PLACED A STEEL WIRE. THE USER COULD NOT ADVANCE THE STEEL WIRE. SO, HE TOOK A TERUMO WIRE 0.035 -150 CM, KNOWING THAT THE TERUMO WIRE WAS NOT ALLOWED TO BE USED FOR THE STEEL NEEDLE PUNCTURE. THE USER NOTED THAT THERE WAS NO OTHER CHOICE BECAUSE HE COULD NOT GET ANY FURTHER WITH THE STEEL WIRE. ACCORDING TO THE USER, HE ONLY PUSHED THE WIRE FORWARD AND NOT BACKWARD. PART OF THE WIRE CAME OFF BUT WAS RETRIEVED. ACCORDING TO THE USER, THE PATIENT DID NOT SUFFER ANY DAMAGE AND WAS ABLE TO LEAVE THE HOSPITAL AS PLANNED. A PART OF THE PRODUCT REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2234531 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO CORPORATION, ASHITAKA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention METAL NEEDLE.