MAUDE Adverse Event Report: Terumo Corporation, Ashitaka GLIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	GS3508
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction

• Brand Name: GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): Terumo Corporation, Ashitaka; 150 maimaigi-cho; fujinomiya, shizuoka 418-0 015; JA 418-0015
• Manufacturer (Section G): Terumo Corporation, Ashitaka; reg. no. 9681834; 150 maimaigi-cho; fujinomiya, shizuoka 418-0 015; JA 418-0015
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; +1(949)989-0491
• MDR Report Key: 50678678
• Report Number: 9681834-2026-00192
• Device Sequence Number: 14785334
• Product Code: DQX
• UDI-Device Identifier: 04987350773630
• UDI-Public: (01)04987350773630(17)260831(10)240924
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: GS3508
• Device Lot Number: 240924
• 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: 08/13/2026
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2024
• 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
• Patient Sex: Unknown