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

Model Number	25-3011
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/17/2025
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: rcis/tech.The actual sample 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 sample 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 work and inspections.After the coil/niti-core wire fixing process, 100% visual inspection is performed to confirm that there is no anomaly such as a kink.After the product assembling process, the outer diameter of coil is measured on 100% basis to confirm that there is no anomaly in it.As a shipping inspection, the bending strength test is performed 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 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." terumo medical corporation (tmc) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).Please refer to section h10 for the importer report on the reported event.
Event or Problem Description
The user facility reported that the distal wire tip separated away from the main body of the wire during a coronary intervention.As a bailout the physician chose to stent the wire up against the vessel wall.Outcome for the patient was satisfactory.No blood loss was reported.Additional information was received on 19feb2025: the patient's anatomy was particularly tortuous at the point of separation.An acute angle/takeoff from the proximal lad into the ostium of the circumflex.Stents were deployed in the circumflex, circumflex ostium, and proximal lad.It was noted that the stents covered the wire segment in question prior to wire removal.Approximately 3-4cm; additionally, the wire segment that separated, was the estimated length of the radiopaque marker.The wire was stented proximal, and ostium of circumflex and proximal lad.The patient was stable.The intended procedure was able to be completed.

• Brand Name: RUNTHROUGH
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 21536908
• Report Number: 9681834-2025-00042
• Device Sequence Number: 7735419
• Product Code: DQX
• UDI-Device Identifier: 04987350720986
• UDI-Public: (01)04987350720986(17)270831(10)240930
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2025

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: 25-3011
• Device Catalogue Number: TW*DS418FH
• Device Lot Number: 240930
• 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: 02/17/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2024
• 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: Required Intervention; Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic