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

Model Number	25-5211
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical received an fda uf/importer report # (b)(4).The event description states: during a stent/angioplasty procedure, part of a guide wire sheared off in the aorta.The remnants of the wire were successfully snared and retrieved.There was no harm to the patient.
Additional Manufacturer Narrative
B3: date of event: october 2024.D4: lot #: requested, unknown.D4: expiration date: unknown, as the involved product lot # was unknown.D4: udi: not available since the involved lot # is unknown di number: (b)(4).D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.H4: device manufacture date: unknown, as the involved product lot # was unknown.The actual device is not available for return; therefore, an evaluation of the actual device was unable to be conducted.Since the involved lot number is unknown, the manufacturing record and the shipping inspection record could not be investigated.In the past complaint file for the product with the involved product code, since its market launch in october 2022, we have not received any reports of events caused by the manufacturing process.Since the involved lot # was unknown, history investigation could not be performed.In addition, since the actual sample was not returned and the analysis 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 the following control.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 on it.After the product assembling process, the tip abutting resistance is measured on 100% basis to confirm that there is no anomaly in the tip load.The quantity of hydrophilic coating solution prepared, and the duration of stirring are controlled to ensure consistent coating amount and uniform coating conditions.In the shipping inspection, the sliding resistance is measured for each lot to confirm that there is no anomaly in its lubricity.The instructions for use (ifu) of this product indicates as follows: manipulate the runthrough ns carefully when crossing it through a deployed stent.Stent migration, stent deformation, or breakage or separation of the runthrough ns may be caused if the runthrough ns is caught by the deployed stent.Terumo medical products (tmp) (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: 21050640
• Report Number: 9681834-2024-00242
• Device Sequence Number: 15864342
• Product Code: DQX
• UDI-Device Identifier: 04987350734709
• UDI-Public: (01)04987350734709
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/01/2025

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: 25-5211
• Device Catalogue Number: 25-5211
• 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: 12/06/2024
• Initial Report FDA Received Date: 01/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown