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	06/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the device broke in the case.When removing the wire, the tip broke off in the patient, and they could not retrieve it.There was no blood loss.The reported event did not result in patient injury and/or require medical or surgical intervention.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: date of birth: 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.E3: occupation: nursing manager.The actual device was not returned.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record.However, since the actual device was not returned and investigation of it could not be performed, 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.In the product assembling process, 100% visual inspection is performed to confirm that there is no deformation in the coil.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, the sliding resistance of distal end is measured for each lot to confirm that there is no anomaly in the lubricity.In the shipping inspection, pulling strength is measured on sampling basis for each product code/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 as shown in fig.2, 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." 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.

• 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: 22468162
• Report Number: 9681834-2025-00122
• Device Sequence Number: 17180983
• Product Code: DQX
• UDI-Device Identifier: 04987350744340
• UDI-Public: (01)04987350744340(17)271031(10)241101
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/16/2025

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: 241101Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 76 KG