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

Model Number	GA3502
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/08/2025
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: vascular surgeon.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# - 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
The user facility reported that they had a peripheral case with an up an over technique by accessing contralateral side to take wire up and over the corina into the opposite iliac.The wire broke while across the steep bifurcating common iliac.The wire broke into two pieces.The part where the wire broke was at the metal area proximal to the hydrophilic part of the wire.The distal broken part of the wire remained in the body when pulling the wire back from catheter and part of the wire remained in the catheter.The wire was removed via a cut down of the other side common femoral artery (cfa) and the case was completed through a cut down endodarctomy of the common femoral artery (cfa) and a endovascular repair and revascularization of the superficial femoral artery (sfa) through the cut down of the common femoral artery (cfa).The estimated blood loss was less than 250cc.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the additional information in section b5 and to update section d9.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Visual and microscopic inspections - it had been fractured at approximately 270mm from the distal end - there was an abrasion at approximately 16mm from the fractured section toward the rear end side - no anomaly was found in other sections.Electron microscopic inspection of the fractured section - radial patterns were found on the fractured surfaces both at the distal side and rear end side.Confirmation of dimensions - outer diameters of the hydrophilic coat and ptfe coat met the factory's specifications.No anomaly was found.History investigation of the product with the involved product code/lot number - no anomaly was found in the manufacturing history record and the shipping inspection record.- no other similar report was found in the past.Past simulation test - continuous torque force was applied while the wire was bent.As a result, the wire was fractured, and radial patterns were found on the fractured surface.- the distal end of wire was clamped with forceps and pulling force was applied.As a result, the wire was fractured, and dimple patterns were found on the fractured surface.- repeated 180° bending force was applied to the wire.As a result, the wire was fractured, side was curved, and dimple patterns were found on the fractured surface.(b)(4) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
Additional information was received on 20aug2025: there was no guiding sheath placed when this occurred.The guidewire advantage (gwa) was going to be used to place a guiding sheath.The tip of the wire was in the common iliac before cutdown and removal.It is unknown which end of the wire was grasped to remove.
Additional Manufacturer Narrative
This report is being sent as follow-up no.2 to update section h3, and to provide the completed investigation results.Simulation test using a factory-retained sample according to the circumstances of the event, glidewire advantage was used without a guiding sheath, and the angle of the mountain of common iliac artery was steep.Therefore, the following simulation test was performed using a simulated lower limb blood vessel model.- the angle of the mountain of common iliac artery of the simulated lower limb blood vessel model was set to r: 10mm - a factory-retained glidewire advantage was inserted alone into the left superficial femoral artery (sfa) via a contralateral approach.- the factory-retained glidewire advantage was inserted until the joint of it was located at the mountain of common iliac artery.- pushing and pulling forces were applied to the glidewire advantage.As a result, the section in the vicinity of joint was deflected toward the aorta side.- torque force was applied to the glidewire advantage.As a result, it was fractured in the vicinity of joint.The location of fracture was the same as that of the actual device, and the fractured section was not tapered and was flat.Electron microscopic inspection of the fractured surface obtained following results.- radial patterns were found on the top surface.- the condition of fractured surface was similar to that of the actual device.Based on the investigation result, as a possible cause of occurrence, it was likely that while the actual device was placed in the steep bifurcation of the common iliac artery, repeated pushing and pulling forces were applied, causing the section in the vicinity of joint to deflect toward the aorta side.Further torque force was then applied, causing metal fatigue to accumulate and leading to fracture.However, since details the condition when the actual device was used and the state of blood stream were unknown, it was not possible to clarify exactly when the event occurred and the extent of the forces applied on the actual device.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 anomaly such as an abrasion.- in the product assembling process, the outer diameter is measured on 100% basis to confirm that there is no localized anomaly in it.The ifu of this product includes the following warnings.- if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the glidewire advantage and/or the catheter and determine the cause by fluoroscopy.- continuing to manipulate or rotate the glidewire advantage or 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.Terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: GLIDEWIRE ADVANTAGE
• 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: 22696656
• Report Number: 9681834-2025-00145
• Device Sequence Number: 21079233
• Product Code: DQX
• UDI-Device Identifier: 04987350703644
• UDI-Public: (01)04987350703644(17)261231(10)250106
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063372
• 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,Followup
• Report Date (Section B): 08/03/2025

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: GA3502
• Device Catalogue Number: RA*CA35265C
• Device Lot Number: 250106
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 08/28/2025
• Initial Report FDA Received Date: 08/03/2025
• Supplement Report FDA Received Date: 08/28/2025; 09/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• 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: 5FR 100CM GLIDECATH; MULTIPLE CATHETERS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown