BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE GUIDEWIRE

    MDR report key: 21050641 · Received January 1, 2025

    Report

    Report Number
    9681834-2024-00225
    Event Type
    Malfunction
    Date Received
    January 1, 2025
    Date of Event
    November 27, 2024
    Report Date
    January 1, 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
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LOT NUMBER: 43K (ESTIMATED TO BE 240307, 240321, 240322, 240326, 240327). D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E1: ESTABLISHMENT ADDRESS: REQUESTED, UNKNOWN. E1: REPORTER NAME : REQUESTED, UNKNOWN. E1: PHONE NUMBER: REQUESTED, UNKNOWN. E2: HEALTH PROFESSIONAL: REQUESTED, UNKNOWN. E3: OCCUPATION: REQUESTED, UNKNOWN. H4: DEVICE MANUFACTURE DATE: REQUESTED, NOT PROVIDED. THE ACTUAL SAMPLE WAS NOT RETURNED; THEREFORE, ANALYSIS OF THE SAMPLE COULD NOT BE CONDUCTED. HISTORY INVESTIGATION OF THE INVOLVED PRODUCT CODE AND LOT# REVEALED NO ANOMALIES IN THE MANUFACTURING OR SHIPPING INSPECTION RECORDS. ADDITIONALLY, NO SIMILAR ISSUES HAVE BEEN REPORTED FROM OTHER FACILITIES. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. SINCE THE ACTUAL SAMPLE 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 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. 9681834.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO UPDATE SECTION D9. THE INITIAL MDR SUBMITTED STATED THAT THE ACTUAL DEVICE WAS NOT AVAILABLE FOR RETURN. HOWEVER, THE DEVICE HAS NOW BEEN RETURNED. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE WIRE COATING WAS PEELING OFF. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE DID NOT CAUSE OR CONTRIBUTE TO A POSITIVE TEST CULTURE, SUSPECTED INFECTION, OR DEATH; HOWEVER, IT DID OCCUR DURING A PROCEDURE. THE PEELED COATING MAY HAVE REMAINED IN THE PATIENT BODY. THE FINAL PATIENT IMPACT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897409 SINGLE USE GUIDEWIRE ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY OCY TERUMO CORPORATION, ASHITAKA OL-XA25455M 43K 04953170358241

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other