MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA SINGLE USE GUIDEWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	OL-XA25455M
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: SINGLE USE GUIDEWIRE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 21050641
• Report Number: 9681834-2024-00225
• Device Sequence Number: 9645143
• Product Code: OCY
• UDI-Device Identifier: 04953170358241
• UDI-Public: (01)04953170358241
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K091417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OL-XA25455M
• Device Catalogue Number: OL-XA25455M
• Device Lot Number: 43K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/01/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown