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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the guidewire broke.The device was reported to fail upon initial clinical use.
Additional Manufacturer Narrative
The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.1.The manufacturing record and the shipping inspection record of the product of the involved product code/august-2022 lot · no anomaly was found.2.The past complaint file of the involved product code/august-2022 lot · no other similar report from other facilities was found.3.Simulation test (fracture of guidewire) a) when a guidewire was pulled until fractured, the side of fractured part of the core wire was found tapered, and a dimple pattern (a hole-shaped pattern) was found on the fracture surface.B) when a guidewire was torqued clockwise and counterclockwise alternately fractured, the side of the fractured part of the core wire was found flat, and a spiral pattern was found on the fracture surface.C) when a guidewire was bent 90° repeatedly until fractured, the side of the fractured part of the core wire was found oblique, and a radial pattern was found on the facture surface.4.Udi no.: (b)(4).Based on the investigation result, as a possible cause of this case, it was inferred that some excessive tensile, torque, or bending force might have been applied to the actual sample, leading to the reported fracture.However, since the actual sample was not returned, the cause of the occurrence could not be clarified.The instructions for use (ifu) of this product includes the following statement.- 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.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• Brand Name: SINGLE USE GUIDWIRE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 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 ; 6402040886
• MDR Report Key: 17604015
• Report Number: 9681834-2023-00177
• Device Sequence Number: 20384954
• Product Code: OCY
• UDI-Device Identifier: 04953170358234
• UDI-Public: 04953170358234
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: D456910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2023

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 Model Number: N/A
• Device Catalogue Number: OL-XS25455M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/23/2023
• 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