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

Model Number	GM1813
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4: weight: 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.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.History investigation of the product with the involved product code/lot number no anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past complaint file.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's report on the reported event.
Event or Problem Description
The user facility reported that the physician was performing a right lower extremity angiogram with intervention.The physician gained access in the left common femoral artery, for up and over access to the right superficial femoral artery (sfa) and popliteal artery.Multiple attempts were made to cross a long segment chronic total occlusion (cto) lesion that began in the p1 segment of the popliteal artery and extended about halfway down into all of the tibial vessels.Retrograde tibial access was gained in both the distal anterior tibial artery as well as the distal posterior tibial artery with cook pedal access sheaths.A 0.018 90cm straight navicross and 0.018 glidewire gold were used to attempt to recannulate the posterior tibial artery into the popliteal.The physician was being fairly aggressive with trying to get thru the chronic total occlusion (cto), as the patient was not a vascular surgical candidate.Towards the very end of the procedure, it was noticed that the distal tip of the glidewire gold wire had broken off in the right lower extremity where the tibioperoneal trunk would have been.The length of the wire left was measured to be approximately 8-9mm.The physicians were not concerned about trying to retrieve the wire tip, as they believed it was extravascular and was within the area where the vessels were already occluded.No attempts were made to retrieve the wire piece and the physicians opened another glidewire gold wire to continue recanalization attempts.The physicians were unable to cross the chronic total occlusion (cto) lesion, so the case was not successful.The physicians stated that they did not believe the piece of wire left behind was problematic and no intervention was needed/required.The patient remained stable throughout and there was no injury to the patient due to the wire piece left behind.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9, section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.Actual device upon receipt - only a guidewire main body.Microscopic inspection - the outer layer had been elongated and a torn shape was found in the fractured section.- no anomaly such as a scratch was found in other sections.Electron microscopic inspection of the wire the outer layer of actual device was removed to confirm the condition of wire at the fractured section.- no taper was found on the side surface of wire at the fractured section.- dimple patterns (hole-shaped patterns) were found on the top surface of wire at the fractured section.Confirmation of dimensions - outer diameter at the normal sections met the factory's specifications.No anomaly was found.Confirmation of the missing length - guidewire main body: approximately 1797mm - since the outer layer had been elongated, it was not possible to measure the exact missing length.History investigation of the product with the involved product code/lot number - no anomaly was found in the manufacturing record and the shipping inspection record.- no other similar report was found in the past.Simulation test regarding the fracture on the guidewire, following simulation test was performed.- repeated 90° bending force was applied to fracture the wire.- no taper was found on the side surface of wire at the fractured section.- dimple patterns were found on the top surface of wire at the fractured section.These conditions were likely to be similar to those of the actual device.(cause of occurrence) based on the investigation result, no anomaly was found in the manufacturing history record and dimensions of the actual device.From the conditions of actual device and simulation test result, as a possible cause of occurrence, it was likely that since repeated bending force was applied, the wire was fractured.When the device was subsequently removed, pulling force was applied, causing the outer layer to elongate and tear, resulting in detachment.In addition, since the outer layer was likely to be elongated, it was not possible to measure the exact missing length.(countermeasure) ashitaka factory assures the quality of this product by performing following controls.- the outer diameter of wire is controlled to assure its strength.- before the packaging process, 100% visual inspection is performed to confirm that there is no anomaly such as a kink or scratch.The ifu of this product includes the following warning: "if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the guide wire m and/or the catheter and determine the cause by fluoroscopy.Failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter, or damage to the vessel." (b)(4) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• Brand Name: GUIDE WIRE M
• 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: 22406876
• Report Number: 9681834-2025-00116
• Device Sequence Number: 8293949
• Product Code: DQX
• UDI-Device Identifier: 04987350774231
• UDI-Public: (01)04987350774231(17)260430(10)240520
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K863138
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2025

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 Expiration Date: 04/30/2026
• Device Model Number: GM1813
• Device Catalogue Number: RF*RB18183TA
• Device Lot Number: 240520
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• 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; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male