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

Model Number	25-1011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: interventional cardiologist.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 complaint file.Please refer to section h10 for the importer's report on the 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.
Event or Problem Description
Terumo medical corporation received the reported information.The doctor stated when he shaped the wire the tip feels like it breaks or was broken.The type of procedure was a left heart catheterization.There was no blood loss.Additional information was received on 27oct2025: the field clinical specialist (fcs) was present for the procedure on (b)(6).During the procedure, the doctor commented that the wire tip seemed broken when he went to shape it.There was no harm caused to the patient.The tip did not separate from the wire however it does feel like it was broken.When was shaped the wire instead of the tip replicating a nice curve, it seemed to kink or break at one point.Additional information was received on 31oct2025: the doctor stated that he has noticed this lately with the tip.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the complete investigation results.Upon receipt, we inspected the returned sample and confirmed that it does not have any anomalies.Accordingly, we have revised the reportability from reportable to not reportable.Appearance confirmation (visual inspection, microscope): the returned device was only a single runthrough.It had been bent in the platinum coil.No anomalies in appearance were found in the other parts.Dimensions: the outer diameters of the platinum coil, the stainless-steel coil, and the shaft: they met the factory's specifications.No anomaly was found.No anomaly was found in the manufacturing record and the shipping inspection record.No similar event was found in the past complaint file.Based on the investigation results, no anomalies were found in the manufacturing history records and in the dimensions.In addition, as a result of the appearance confirmation, no anomaly indicated in the complaint was found in the actual device, and it was not possible to identify the cause of occurrence.Ashitaka factory is committed to maintaining the quality of the product by performing the following control.In the product assembling process, 100% visual inspection is performed to ensure that there is no deformation in the coil.After the product assembling process, the outer diameter is measured on 100% basis to ensure that there is no anomaly on it.In the shipping inspection, the sliding resistance is measured per each lot to ensure that there is no anomaly in its lubricity.In the shipping inspection, tensile strength is measured on a sampling basis per product code and lot to ensure that there is no anomaly in the strength.The instructions for use (ifu) of this product indicates as follows: "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.".

• 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; reg. no. 9681834; 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: 23524149
• Report Number: 9681834-2025-00208
• Device Sequence Number: 10187251
• Product Code: DQX
• UDI-Device Identifier: 04987350744340
• UDI-Public: (01)04987350744340(17)280531(10)250610
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

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: 25-1011
• Device Catalogue Number: TW*AS418XA
• Device Lot Number: 250610Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• 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