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

Model Number	GS3510
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported they were unable to backload a catheter onto the wire.When trying to backload the catheter on to the wire, the hydrophilic material at the back of the wire would bunch up and prevent the catheter from being advanced.The wire was removed and a new glidewire was inserted.The case was completed with no further issues.No blood loss.There was no patient injury and/or require medical or surgical intervention.No blood loss was reported.Additional information was received on 09jan2025: the procedure performed was an aortagram with runoff of lower leg.There was no impact to the patient from the hydrophilic material bunching up.The wire was exposed when the hydrophilic material bunched up.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.6b: 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.No anomaly was found in the manufacturing record and the shipping inspection record.No similar event was found in the past complaint file.Terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Please see mdr 2243441-2025-00001 for the importer report on this reported event.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.The actual sample upon receipt was only a main body.Microscopic inspection of the actual sample: intermittent abrasions were found at approximately 240mm - 285mm from the distal end.Continuous abrasions were found at approximately 485mm - 579mm from the distal end.The urethane layer had been worn down, the wire had been exposed, and an abrasion was found at approximately 2500mm from the distal end.The urethane layer had been peeled off, the wire had been exposed, the urethane layer had been worn down, and an abrasion was found at approximately 2504mm - 2510mm from the distal end.The outer layer had been twisted at approximately 2579mm from the distal end.The outer layer had been fractured and the torn shape was found at the rear end.No anomaly was found in other sections.Electron microscopic inspection of the actual sample: the outer layer at the fractured section of actual sample was removed to expose the wire.The side of wire at the fractured section was not tapered, and the fractured surface had been diagonal.The side of wire at the fractured section had been dented.The fixed size cut marks were found at the top surface of wire at the fractured section.Electron microscopic inspection of the product with the involved product code: the outer layer at the rear end of the product with the involved product code was removed to expose the wire.The side of wire at the rear end was not tapered, and the fractured surface had been diagonal.The side of wire at the fractured section had been dented.The fixed size cut marks were found at the top surface of wire at the rear end.These conditions were likely to be similar to those of the actual sample.It was inferred that the wire of actual sample was not fractured, and the outer layer was elongated.Confirmation of the dimension: the outer diameter met the factory's specifications.No anomaly was found.Confirmation of the missing length: since the outer layer was likely to be elongated, it was not possible to measure the exact missing length.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past.Simulation test: excessive torque force with the torque device.[test method]: with the torque device fastened to the guidewire, it was pushed toward the distal direction while applying torque force.[test result]: the wire was exposed.The outer layer was abraded, fractured and elongated.The outer layer was twisted.Abrasive force with the torque device.[test method]: the rear end of guidewire was clamped with a metallic torque device, and abrasive force was applied in the rear direction.[test result]: the outer layer was peeled off in the vicinity of rear end.The torn shape was found in the outer layer.The urethane layer was peeled off.Based on the investigation result, no anomaly was found in the manufacturing history record and the dimension of actual sample.As a possible cause of occurrence, the following mechanisms were inferred.However, since the details of procedure were unknown, it was not possible to clarify what the hard object was.The distal end of actual sample got stuck with some hard object.In that state, the actual sample was manipulated, causing abrasions.In an attempt to release the stuck, a clamping object (e.G., torque device) was used to apply torque while pushing and pulling operation, which caused the urethane to peel off and be worn down.Pulling force was then applied by the removal operation, causing the outer layer to elongate and be missing.Ashitaka factory manufacturing process assures the quality of this product by performing following work and inspections.100% insertion inspection is performed by passing a guidewire through the dedicated tool to confirm that the outer layer is not peeled off or a foreign substance is not adhered to the surface of guidewire.Before the packaging process, 100% visual inspection is performed to confirm that there is no anomaly such as peeling of the outer layer on the surface of guidewire.Instructions for use (ifu) of this product includes the following precaution and warning: "do not slip a tightened-up torque device or y-connector over the wire, as this may result in damage to the wire." "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.Continuing to manipulate or rotate the guide wire m 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.".

• 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
• 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: 21293987
• Report Number: 9681834-2025-00009
• Device Sequence Number: 9208074
• Product Code: DQX
• UDI-Device Identifier: 04987350773678
• UDI-Public: (01)04987350773678(17)260331(10)240424
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/03/2025

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 Expiration Date: 03/31/2026
• Device Model Number: GS3510
• Device Catalogue Number: RF*PA35265A
• Device Lot Number: 240424
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White