BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GLIDEWIRE ADVANTAGE

    MDR report key: 17658234 · Received August 30, 2023

    Report

    Report Number
    9681834-2023-00169
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    July 29, 2023
    Report Date
    August 30, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. G4: PMA/510(K): K063372, K122590, K163004. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, A PHOTO OF THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. THE PROVIDED PICTURE OF THE ACTUAL SAMPLE SHOWED A SEPARATION OF URETHANE LAYER TOWARD THE DISTAL DIRECTION. HISTORY INVESTIGATION WAS CONDUCTED. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT # FOUND NO ANOMALY IN THEM. A SEARCH OF THE PAST COMPLAINT FILE REGARDING THE INVOLVED PRODUCT CODE/LOT FOUND NO OTHER SIMILAR REPORT FROM OTHER FACILITIES. PAST SIMULATION TESTING WAS CONDUCTED. TEST METHOD: (1) AN ABRASION WAS MADE TO THE URETHANE LAYER OF A TEST SAMPLE (ADVANTAGE). (2) THE TEST SAMPLE WAS PULLED IN THE WITHDRAWAL DIRECTION AND DRAWN INTO THE CATHETER. (3) WHILE THE ABRASION AREA OF THE TEST SAMPLE WAS CAUGHT ON THE CATHETER, THE PULLING OPERATION WAS CONTINUED. CAUSE OF OCCURRENCE/CONCLUSION FROM THE RESULTS OF THE INVESTIGATION, AS ONE OF THE POSSIBILITIES, IT WAS THOUGHT THAT THIS EVENT WAS CAUSED BY THE FOLLOWING MECHANISM; HOWEVER, SINCE THE DETAILS AT THE TIME OF USE WERE UNKNOWN, IT WAS NOT POSSIBLE TO CLARIFY THE TIMING OF OCCURRENCE. (1) WHEN THE ACTUAL SAMPLE WAS USED IN COMBINATION WITH THE CATHETER, THE URETHANE LAYER OF THE ACTUAL SAMPLE WAS ABRADED BY SOME HARD OBJECT (E.G., STENOTIC LESION). (2) WHEN THE ACTUAL SAMPLE IN THE STATE OF (1) WAS PULLED INTO THE CATHETER (WITHDRAWAL OPERATION), THE ABRASION AREA WAS CAUGHT IN THE CATHETER. (3) AS THE WITHDRAWAL OPERATION CONTINUED IN THE STATE OF (2), THE URETHANE WAS PEELED TOWARD THE DISTAL DIRECTION. RELEVANT INSTRUCTIONS FOR USE (IFU)REFERENCE: IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIREADVANTAGE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. CONTINUING TO MANIPULATE OR ROTATE THE GLIDEWIREADVANTAGE OR FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE INVOLVED DAMAGED GLIDEWIRE ADVANTAGE 0.014 WAS BEING USED DURING A LOWER LIMB PROCEDURE. ONCE THE WIRE WAS BEING NEGOTIATED ACROSS THE LESION WITH A SUPPORT CATHETER NAVICROSS OVER IT, RESISTANCE WAS FELT. WHEN BOTH THE DEVICES WERE TAKEN OUT, IT WAS FOUND THAT THE COATING ON DISTAL END OF THE ADVANTAGE WIRE HAD PEELED OFF AND HAD BECOME UNEVEN. WHICH ALSO DAMAGED THE NAVICROSS. THE 0.014 ADVANTAGE WIRE WAS REMOVED, AND ANOTHER 0.014 WIRE WAS USED. THE PEELED PIECE HAS NOT BEEN REMAINED IN THE PATIENT'S BODY. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT WAS NOT INJURED, MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THE PATIENT'S FINAL IMPACT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202166 RADIFOCUS GLIDEWIRE ADVANTAGE WIRE, GUIDE, CATHETER DQX TERUMO MEDICAL CORPORATION N/A 220516

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown