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

Model Number	25-1011
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Codes	Perforation (2001); Foreign Body In Patient (2687)
Date of Event	08/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a high-risk percutaneous coronary intervention (pci) in a very tortuous om branch of the circumflex artery.There was no trouble getting the run-through wire down past the area of interest with a "safety loop" although it did straighten out a very significant loop in the artery.When the physician tried to pull the run-through wire back, he stated that the wire "was stuck".He did not pull hard; however, did some gentle tugging on the wire a couple times and the wire ended up breaking off inside the coronary artery.We were unable to retrieve the distal end of the wire, and the patient was not a surgical candidate.Therefore, the physician decided to pin the wire by placing three (3) stents to cover the wire from the distal part of the artery all the way to the ostium.This was an outpatient planned pci.The patient went to the lab stable, and all vitals were within normal limits.The blood loss was less than 250cc.The remaining wire was wiped clean, then placed in a biohazard bag post procedure.Additional information was received on 15aug2025: the images were reviewed, which did demonstrate a highly tortuous om artery.The vessel was perforated; however, it was reported that the broken segment of the wire did not cause the perforation.A balloon (sapphire) was used with the wire.The patient was stable.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: lead tech.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 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 coil had been elongated (the coil pitch had been opened) near the joint of the stainless-steel coil and platinum coil, and niti-core wire.The niti-core wire had been exposed from the fractured section to the joint of the niti-core wire.No anomaly was found in other sections.Electron microscopic inspection of the fractured section: dimple patterns (hole-shaped patterns seen during fatigue failure) were found on the top surface of the fractured section at the niti-core wire.It was inferred that bending force was applied to the involved section and it was fractured.Confirmation of dimensions: the platinum coil section was severely damaged, and its outer diameter could not be measured.Outer diameters of the stainless-steel coil section and the shaft met the factory's specifications.No anomaly was found.Confirmation of the missing length: the length of niti-core wire from the fractured section to the joint of the stainless-steel coil and platinum coil, and niti-core wire: approximately 17mm.Since the length of platinum coil is approximately 30mm, it was likely that the missing length was approximately 13mm.No anomaly was found in the manufacturing history record and the shipping inspection record.No other similar report was found in the past complaint file.Past simulation test: while getting stuck at the distal end of coil, repeated 90° bending force was applied.As a result, the niti-core wire was fractured.In addition, dimple patterns (hole-shaped patterns seen during fatigue failure) were found on the top surface of the fractured section at the niti-core wire.Based on the investigation result, no anomaly was found in the manufacturing history records and the dimensions at the normal sections.From the condition of actual device and the simulation test result, as a possible cause of occurrence, it was likely that since the distal end got stuck for some factor, and repeated 90° bending force was applied in that state, metal fatigue occurred, and niti-core wire fractured.Then, during operation, the platinum coil elongated and fractured.However, since the details of procedure were unknown, it was not possible to clarify the cause of stuck.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 on 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 on sampling basis 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 lot 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.".

• 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: 22940350
• Report Number: 9681834-2025-00165
• Device Sequence Number: 9800990
• Product Code: DQX
• UDI-Device Identifier: 04987350744340
• UDI-Public: (01)04987350744340(17)280229(10)250307
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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: 250307Y
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON (SAPPHIRE).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White