BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE GUIDEWIRE

    MDR report key: 21078500 · Received January 6, 2025

    Report

    Report Number
    9681834-2024-00241
    Event Type
    Injury
    Date Received
    January 6, 2025
    Date of Event
    December 5, 2024
    Report Date
    January 6, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    OCY
    UDI-DI
    04953170358241
    PMA / PMN Number
    K091417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LOT NUMBER: 3XK (ESTIMATED TO BE 231003, 231004, 231010, 231030). THERE WAS A DISCREPANCY BETWEEN THE OLYMPUS PRODUCT CODE (G-260-3545A) AND THE TERUMO PRODUCT CODE (OL-XA25455M), AND THIS WAS CURRENTLY BEING CONFIRMED AS OF (B)(6) 2024. VISUAL INSPECTION OF THE ACTUAL SAMPLE: THE DISTAL SECTION WAS APPROXIMATELY 41 MM IN LENGTH AND THE CORE WIRE WAS EXPOSED. AS THE SAME SECTION OF A COMPARABLE-LOT SAMPLE WAS APPROXIMATELY 76 MM, THE ACTUAL SAMPLE WAS CONFIRMED TO BE APPROXIMATELY 35 MM SHORTER. MAGNIFYING INSPECTION: THE DISTAL END OF THE OUTER LAYER HAD A TORN-OFF SHAPE. THERE WERE SCRATCHES ON THE GOLD COIL NEAR THE DISTAL END OF THE OUTER LAYER. THERE WERE SCRATCHES ON THE OUTER LAYER AT APPROXIMATELY 1350MM FROM THE DISTAL END AND IN THE AREA APPROXIMATELY 1980MM-2040MM FROM THE DISTAL END. THERE WERE NO ANOMALIES IN OTHER AREAS, SUCH AS SCRATCHES. ELECTRON MICROSCOPIC INSPECTION OF THE ACTUAL SAMPLE: THE DISTAL END OF THE CORE WIRE WAS DEFORMED IN A TAPER SHAPE. DIMPLE PATTERN WAS OBSERVED ON THE TOP SURFACE OF THE CORE WIRE. DIMENSIONS: THE OUTER DIAMETER (UNDAMAGED AREA) MET THE CONTROL STANDARDS FOR 0.035-INCH PRODUCTS. FROM THIS, THE ACTUAL SAMPLE WAS JUDGED TO BE A 0.035-INCH PRODUCT. HISTORY INVESTIGATION OF (B)(6) 2023-LOT PRODUCTS (3XK) (OL-XA35455 AND OL-XA25455M): NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF ALL POSSIBLE PRODUCT CODE-LOT COMBINATIONS. REGARDING ALL POSSIBLE PRODUCT CODE-LOT COMBINATIONS, NO SIMILAR EVENTS WERE REPORTED FROM OTHER FACILITIES. SIMULATION TEST: THE FOLLOWING SIMULATION TEST WAS CARRIED OUT. A TEST SAMPLE WAS PULLED IN THE PROXIMAL DIRECTION WHILE HOLDING FORCE WAS APPLIED TO ITS DISTAL END. THE DISTAL END OF THE CORE WIRE WAS DEFORMED IN A TAPER SHAPE. DIMPLE PATTERN WAS OBSERVED ON THE TOP SURFACE OF THE CORE WIRE. THE CONDITION OF THE TEST SAMPLE WAS CONSIDERED TO BE SIMILAR TO THAT OF THE ACTUAL SAMPLE. FROM THE RESULTS OF THE INVESTIGATION, NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORD AND DIMENSIONS OF THE ACTUAL SAMPLE. AS ONE OF THE POSSIBILITIES, FROM THE SIMULATION TEST, IT IS CONSIDERED PROBABLE THAT THE ACTUAL SAMPLE WAS PULLED IN THE PROXIMAL DIRECTION WHILE ITS DISTAL END WAS PUT HOLD BETWEEN SOME HARD OBJECTS, LEADING TO THE FRACTURE OF THE DISTAL END AND SCRATCHES ON THE GOLD COIL AND THE OUTER LAYER. SINCE THE ACTUAL SAMPLE WAS APPROXIMATELY 35MM SHORTER THAN THE COMPARABLE-LOT SAMPLE, IT WAS INFERRED THAT THERE WAS A MISSING PORTION OF APPROXIMATELY 35 MM IN LENGTH 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 GUIDE WIRE AND/OR ENDOTHERAPY ACCESSORY AND DETERMINE THE CAUSE BY FLUOROSCOPY OR ENDOSCOPE. CONTINUING TO MANIPULATE THE GUIDEWIRE COULD CAUSE PATIENT INJURY, SUCH AS PUNCTURES, HEMORRHAGES OR MUCOUS MEMBRANE DAMAGE. IT MAY ALSO DAMAGE THE ENDOSCOPE, INSTRUMENT AND/OR ENDOTHERAPY ACCESSORY." 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).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE A CORRECTION TO SECTION D4.

    Additional Manufacturer Narrative · 0

    D4: LOT NUMBER: 231005, 231026, 231031. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 TO PROVIDE ADDITIONAL INFORMATION TO SECTION D4 AND PROVIDE ADDITIONAL INVESTIGATION RESULTS. SINCE DETAILED INFORMATION FOR LOT 3XK WAS NOT AVAILABLE, IT WAS DECIDED TO INVESTIGATE THREE POSSIBLE LOTS (231005, 231026, 231031). HISTORY INVESTIGATION OF THE PRODUCT WITH THE POSSIBLE THREE LOTS WAS PERFORMED. NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD FOR THREE LOTS. NO OTHER SIMILAR REPORT FROM OTHER FACILITIES WAS FOUND FOR THREE LOTS. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING HISTORY RECORD AND DIMENSIONS FOR THREE POSSIBLE LOTS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE GUIDEWIRE G-260-3545A HAD POOR LUBRICATION WHEN COMBINED WITH AN ANGIOGRAPHIC TUBE (ERCP CATHETER FROM MTW), LEADING TO PEELING OF OUTER JACKET AT THE DISTAL END. IT WAS REPLACED WITH A DEVICE OF THE SAME TYPE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PRODUCT WAS FRACTURED, AND A FRAGMENT POTENTIALLY REMAINED IN THE PATIENT; HOWEVER, THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962180 SINGLE USE GUIDEWIRE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY TERUMO CORPORATION, ASHITAKA OL-XA35455M 3XK 04953170358241

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other ERCP CATHETER FROM MTW.