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

Model Number	GA3502
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user faculty reported that radial to peripheral cases resulted in a significant aortic dissection from the heart to the distal aorta.It is unclear if the glidewire advantage was the cause of the dissection.The equipment used included the glidewire advantage, 400 stiff angle glide, 119cm destination slender, and 200cm navicross.The dissection was not noticed during the procedure, but the patient later required open surgery and experienced shutdown of the opposite leg.Blood loss was less than 250cc.The reported event resulted in patient injury and required medical or surgical intervention.Surgery was necessary to repair the total aortic dissection and the clotted left leg.The event occurred post-operatively.
Additional Manufacturer Narrative
D4: lot #: requested, unknown.D4: expiration date: unknown, as the involved product lot # was unknown.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.A historical investigation of the product with the product code/lot# involved was conducted.However, since the lot# was unknown, the manufacturing record and the shipping inspection record could not be investigated.Additionally, the past complaint file could not be reviewed due to the unknown lot#.Since the lot# was unknown, historical investigation could not be performed.In addition, 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 controls.The outer diameter of this product is controlled.In the product assembling process, 100% visual inspection is performed to confirm that there is no anomaly in the appearance.The instructions for use (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 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.For information regarding the importer report for this event, please refer to section h10.

• 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: 21517276
• Report Number: 9681834-2025-00022
• Device Sequence Number: 8455367
• Product Code: DQX
• UDI-Device Identifier: 04987350703644
• UDI-Public: 04987350703644
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2025

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 Model Number: GA3502
• Device Catalogue Number: RA*CA35265C
• 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: 02/03/2025
• Initial Report FDA Received Date: 03/04/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 119CM DESTINATION SLENDER; 200CM NAVICROSS; 260 GLIDEWIRE ADVANTAGE OMNIFLUSH; 400CM STIFF GLIDEWIRE; 6FR GLIDESHEATH SLENDER
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown