BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE

    MDR report key: 18668031 · Received February 8, 2024

    Report

    Report Number
    9681834-2024-00010
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Date of Event
    January 16, 2024
    Report Date
    February 8, 2024
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PMA/510(K): K923607, K926214 VISUAL INSPECTION OF THE ACTUAL SAMPLE FOUND THAT THE LENGTH OF THE FRAGMENT WAS APPROXIMATELY 131 MM. LENGTH OF THE MAIN BODY WAS APPROXIMATELY 3861MM. THE TOTAL LENGTH WAS APPROXIMATELY 3992 MM. THE TOTAL LENGTH OF THE ACTUAL SAMPLE WAS CONFIRMED TO BE WITHIN OUR CONTROL STANDARDS. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE FOUND THAT EXPOSURE OF THE CORE WIRE WAS OBSERVED AT THE FRACTURE OF THE FRAGMENT. THE FRACTURED EDGE OF THE OUTER LAYER OF THE MAIN BODY WAS STRETCHED. THE TOP SURFACE OF BOTH FRACTURES SHOWED TWISTED OUTER LAYER. NO ANOMALY SUCH AS A SCRATCH WAS FOUND IN OTHER SECTIONS. ELECTRON MICROSCOPIC INSPECTION OF THE ACTUAL SAMPLE FOUND THAT WRINKLES WERE OBSERVED ON THE OUTER LAYER NEAR THE FRACTURED PART OF BOTH PORTIONS. THE FRACTURED EDGE OF THE OUTER LAYER OF BOTH PORTIONS SEEMED TO HAVE BEEN TORN OFF. DIMENSION OF THE ACTUAL SAMPLE FOUND THAT THE OUTER DIAMETER (UNDAMAGED PART IN THE VICINITY OF THE FRACTURE) WAS CONFIRMED TO MEET THE FACTORY'S SPECIFICATIONS. NO ANOMALY WAS FOUND. NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORD AND THE PRODUCT INSPECTION RECORD. NO OTHER SIMILAR REPORT FROM OTHER FACILITIES WAS FOUND IN THE PAST COMPLAINT FILE. SIMULATION TEST: FROM THE CONDITION OF THE ACTUAL SAMPLE, IT WAS ASSUMED THAT TORQUE LOAD AND PULLING LOAD WERE APPLIED TO THE ACTUAL SAMPLE. BASED ON THIS ASSUMPTION, THE FOLLOWING SIMULATION TEST WAS CONDUCTED. THE GUIDE WIRE WAS HELD CURVED AND EXPOSED TO CONTINUOUS ONE-WAY TORQUE LOAD UNTIL A FRACTURE OF CORE WIRE OCCURRED. SUBSEQUENTLY, TORQUE LOAD AND PULLING LOAD WERE APPLIED. AS A RESULT, THE GUIDEWIRE WAS FRACTURED, AND THE FOLLOWING CHARACTERISTICS WERE RECOGNIZED ON THE TESTED SAMPLE. A SHAPE THAT LOOKED LIKE THE OUTER LAYER HAD BEEN TORN OFF WAS OBSERVED AT BOTH FRACTURED PARTS. EXPOSURE OF THE CORE WIRE WAS OBSERVED AT THE FRACTURE OF THE FRAGMENT. THE FRACTURED EDGE OF THE OUTER LAYER OF THE MAIN BODY WAS STRETCHED. THE TOP SURFACE OF BOTH FRACTURES SHOWED TWISTED OUTER LAYER. FROM THIS RESULT, IT WAS CONSIDERED THAT THE CONDITION OF THE TESTED SAMPLE WAS SIMILAR TO THAT OF THE ACTUAL SAMPLE. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD, THE SHIPPING INSPECTION RECORD, AND DIMENSIONS OF THE ACTUAL SAMPLE. AS ONE OF THE POSSIBILITIES, IT WAS INFERRED THAT THE ACTUAL SAMPLE WAS SUBJECTED TO EXCESSIVE TORQUE LOAD AND PULLING LOAD, LEADING TO THE FRACTURE. SINCE THE TOTAL LENGTH OF THE ACTUAL SAMPLE WAS CONFIRMED TO BE WITHIN OUR CONTROL STANDARDS, IT WAS LIKELY THAT THERE WAS NO PORTION MISSING FROM THE ACTUAL SAMPLE. 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 GLIDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. 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. (B)(4)

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE GUIDEWIRE WAS USED WITH MTW ERCP CATHETER FROM ABIS. AFTER REPEATEDLY PUSHING AND PULLING MANIPULATION AT THE OCCLUDED AREA, A FRACTURE AT THE DISTAL END WAS NOTICED. WHEN THE CATHETER WAS PULLED OUT, THE FRACTURED PIECE OF WIRE WAS EXTRACTED ALONG WITH THE CATHETER. IT WAS REPLACED WITH ANOTHER NEW ONE AND THE PROCEDURE CONTINUED. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO RESIDUE IN THE PATIENT, IT WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792504 RADIFOCUS GUIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO MEDICAL CORPORATION N/A 230929

    Patients

    Seq Age Sex Outcome Treatment
    1