MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RUNTHROUGH; WIRE, GUIDE, CATHETER

Model Number	25-1011
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that a piece of the device's tip broke off in the patient's aorta.The procedure performed was a coronary percutaneous coronary intervention (pci).
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past.Please refer to section h10 for the importer report on this reported event.Terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.Visual and microscopic inspections: the actual device upon receipt was only a runthrough ns.The platinum coil section and niti-core wire had been fractured.The platinum coil section had been elongated (the coil pitch had been opened).The niti-core wire had been exposed approximately 26mm from the fractured section.No anomaly was found in other sections.Electron microscopic inspection of the fractured section: dimple patterns were found on the top surface at the fractured section.The side surface at the fractured section had been tapered.It was inferred that since pulling force was applied, it was fractured.Confirmation of dimensions: the platinum coil section had been severely damaged and could not be measured.Dimensions of the stainless-steel coil section and the shaft met the factory's specifications.No anomaly was found.Confirmation of the missing length: length of the niti-core wire from the fractured section of main body to the joint of the stainless- steel coil and platinum coil, and niti-core wire: approximately.26mm.Since the length of platinum coil section is 30mm, it was inferred that the missing length was approximately 4mm.No anomaly was found in the manufacturing record and the shipping inspection record.Past simulation test: the distal end of device was trapped and pulling force was applied.As a result, the niti-core wire was fractured at the platinum coil section.The dimple patterns and the taper were found at the fractured surface.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.As a possible cause of this case, it was likely that the distal end of device was trapped for some factor, and pulling force was applied in that state, causing it to fracture.However, since the details of procedure were unknown, it was not possible to clarify the cause of occurrence.Ashitaka factory has been making efforts in maintaining the quality of the product by performing following controls.After the product assembling process, the outer diameter is measured on 100% basis to confirm that there is no anomaly in it.In the shipping inspection, pulling strength is measured on sampling basis for each lot number to confirm that there is no anomaly in it.The instructions for use (ifu) of this product includes the following warning: "if any resistance to the runthrough ns or the dilatation catheter is felt during manipulation or if the shape, behaviour or position of the guide wire's tip seems improper, e.G., in a case where the tip is trapped due to vessel spasm or some other cause or the tip is folded, stop manipulating the guide wire (and the catheter) and determine the cause carefully by fluoroscopy and take suitable remedial actions.Then remove the guide wire slowly, without turning, to exchange it for a new one.Continuing guide wire or catheter manipulation in the said situations may result in damage to the vessel, damage to or separation of the guide wire's tip, and/or damage to the dilatation catheter.".

• Brand Name: RUNTHROUGH
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 22726016
• Report Number: 9681834-2025-00152
• Device Sequence Number: 15739191
• Product Code: DQX
• UDI-Device Identifier: 04987350744340
• UDI-Public: (01)04987350744340(17)270731(10)240823
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K063695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: 25-1011
• Device Catalogue Number: TW*AS418XA
• Device Lot Number: 240823Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• 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