BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE GUIDEWIRE

    MDR report key: 22077952 · Received May 23, 2025

    Report

    Report Number
    9681834-2025-00081
    Event Type
    Injury
    Date Received
    May 23, 2025
    Date of Event
    April 18, 2025
    Report Date
    May 23, 2025
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    OCY
    PMA / PMN Number
    K091417
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. A3A: SEX: REQUESTED, NOT PROVIDED. A4: WEIGHT: REQUESTED, NOT PROVIDED. A5: ETHNICITY: REQUESTED, NOT PROVIDED. A6: RACE: REQUESTED, NOT PROVIDED. D4: LOT NUMBER: 49K (ESTIMATED TO BE 240910, 240930). D4: UDI: (01)04953170358241 (SINCE LOT NO. IS UNKNOWN, ONLY DI NO. IS LISTED.). D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: ADDRESS: REQUESTED, UNKNOWN. E1: TELEPHONE NUMBER: REQUESTED, UNKNOWN. E2: HEALTH PROFESSIONAL: REQUESTED, UNKNOWN. E3: OCCUPATION: REQUESTED, UNKNOWN. THE ACTUAL DEVICE WAS NOT RETURNED. SINCE THE ACTUAL DEVICE WAS NOT RETURNED, INVESTIGATION OF IT COULD NOT BE PERFORMED. HISTORY INVESTIGATION OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER - NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. - NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST. CAUSE OF OCCURRENCE/CONCLUSION: BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. SINCE THE ACTUAL DEVICE WAS NOT RETURNED AND INVESTIGATION OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. 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 CORPORATION (TMC) (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 GUIDEWIRE FRONT COATING PEELED OFF. REPORTEDLY, THIS ISSUE INVOLVES THE FOLLOWING OLYMPUS PRODUCT G-260-2545A. ACCORDING TO THE AVAILABLE INFORMATION, THIS ISSUE DID NOT CAUSE OR CONTRIBUTE TO A POSITIVE TEST CULTURE, (SUSPECTED) INFECTION, OR DEATH; DURING A PROCEDURE. THE PEELED COATING MAY HAVE REMAINED IN THE PATIENT BODY. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2515162 SINGLE USE GUIDEWIRE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY TERUMO CORPORATION, ASHITAKA OL-XA25455M 49K

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other