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

Model Number	N/A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that when opening the bile guide to insert it into the papillotome, it was noticed that there was a portion of it without the cover.There were no problems with the patient.Another bile guide used.The procedure outcome was not reported.The final patient impact was not harmed.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided a2: age & date of birth: requested, not provided a3: patient sex: requested, not provided a4: weight: requested, not provided a5: ethnicity: requested, not provided a6: race: requested, not provided d6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e1: initial reporter name : unknown e2: health professional: unknown e3: occupation: unknown the actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Review of the manufacturing record and the shipping inspection record of the product with the involved product code/manufacturing lot of november 2022 (2yk) confirmed that there was not any anomaly leading to the complaint in them.A search of the complaint file found no other similar report of the product with the involved product code/lot number from other facilities.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Additional Manufacturer Narrative
H6: investigation findings - code 3211 is based upon the evaluation of user facility information and the investigation of the images received; code 3221 is based upon no sample returned.The actual sample was not available; however, images were provided.From the provided images, it was confirmed that "there was a portion of it without the cover" described in the complaint form was located in the center of actual sample and spanned approximately 25mm.There is a section in the vicinity of the joint of wire on the involved product (approximately 1330mm - 1355mm from the distal end) that is not coated with ptfe.It was inferred that "there was a portion of it without the cover" described in the complaint form was likely to be an uncoated section in the vicinity of the joint, which exists due to the manufacturing process.The manufacturing record and the shipping inspection record of the product with the lot of november 2022 (2yk), no anomaly was found.No other similar report from other facilities was found.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.From the provided images, it was inferred that the portion described in the complaint form was likely to be an uncoated section in the vicinity of the joint of wire.However, since investigation of the actual sample could not be performed, it was not possible to identify the cause of occurrence.Relevant instructions for use (ifu) reference: "before use, prepare and inspect the instrument as instructed below.Should the slightest irregularity be suspected, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient.".
Additional Manufacturer Narrative
This report is being sent as follow-up no.2 to correct section d3.

• Brand Name: SINGLE USE GUIDEWIRE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, MD 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 18168533
• Report Number: 9681834-2023-00243
• Device Sequence Number: 15140461
• Product Code: OCY
• UDI-Device Identifier: 04953170282867
• UDI-Public: 04953170282867
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Followup
• Report Date (Section B): 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: N/A
• Device Catalogue Number: OL-XS35453M
• Device Lot Number: 2YK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 01/29/2024; 02/10/2025
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 02/23/2024; 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown