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

Model Number	GS3543
Medical Device Problem Codes	Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the doctor had a 450cm stiff angled glidewire going from the left radial artery to the right peroneal artery and proceeded to introduce a 3mmx100mm metacross r2p balloon into the popliteal artery where he began inflating to nominal pressures all along the popliteal and superficial femoral arteries with good success.The balloon was then brought back through the destination slender 119cm sheath and exited to sheath without issue.Once the balloon was out of the sheath about 20cm it stopped tracking on the stiff glidewire.The doctor tried pulling hard with hands, then with clamps and finally to release it with a knife to no avail, the balloon was stuck on the wire.He had to take the wire out of the body and get a new wire.The procedure was a radial to right leg percutaneous transluminal angioplasty (pta).Additional information was received from kaneka regarding the investigation of their device and the reported glidewire on 25apr2025: the catheter was returned with the glidewire (gw) stuck inside.Multiple sections of the glidewire (gw) showed peeled coating, shaft deformation, and fractures.The inner shaft was found adhered to the glidewire (gw) and deformed into a bellows shape, with fractures at approximately 2,495 mm and 3,519 mm from the tip.The outer shaft and core wire also exhibited bellows-like deformation and tip damage.The glidewire (gw) port was located at 3,605 mm with a fracture just beyond.The core wire had shifted and detached from the hub.Additionally, one ring marker was found embedded in the deformed shaft section.It is considered that the increased sliding resistance between the glidewire (gw) lumen and the glidewire (gw) forced the catheter to be pushed and pulled strongly, causing deformation of the inner shaft and breakage of the shaft.The reason why the sliding resistance between the glidewire (gw) lumen and the glidewire (gw) was increased is assumed that the hydrophilic coating performance of the glidewire (gw) was reduced, or the sliding characteristics were reduced due to blood adhesion.

• Brand Name: GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• MDR Report Key: 22077951
• Report Number: 2243441-2025-00019
• Device Sequence Number: 9363603
• Product Code: DQX
• UDI-Device Identifier: 04987350726704
• UDI-Public: (01)04987350726704(17)250831(10)230919
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2025
• Report Date (Section F): 05/23/2025

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: 08/31/2025
• Device Model Number: GS3543
• Device Catalogue Number: RF*PA35453P
• Device Lot Number: 230919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/25/2025
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 119CM DESTINATION SLENDER; 3MM X 100MM METACROSS R2P BALLOON
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/23/2025