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

Model Number	GA1430
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: 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.History investigation of the product with the involved product code/lot number no anomaly was found in the manufacturing record and the shipping inspection record.No other similar report was found in the past.Terumo medical corporation (tmc) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).For information regarding the importer report for this event, please refer to section h10.
Event or Problem Description
The user facility reported that the wire was stripped.They opened another wire to use, and the case was completed successfully.There was no harm to the patient and no blood loss.The procedure performed was an angiogram.Additional information was received on 25feb2025: the issue was discovered inside of the body.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9, section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.Visual and microscopic inspections no anomaly such as a fracture was found over the entire length.The distal end had been bent.The outer layer at the distal end had been dented.The outer layer at the distal end had been abraded in multiple sections.The ptfe coating had been intermittently peeled off at approximately 356mm - 1300mm from the distal end.No anomaly was found in other sections.Confirmation of dimensions: outer diameters of the hydrophilic coating and ptfe coating at the normal sections 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 record and the shipping inspection record.No other similar report was found in the past complaint file.Past simulation test: [bend due to abrasive force] the simulated blood vessel was occluded, and a factory-retained radifocus glidewire advantage was got stuck, and the removal operation was performed.Abrasive force was applied to the occluded section, causing it to bend in a three-dimensional manner.[peeling of ptfe coating due to metal device] the removal operation was performed in a curved state inside the metal device, and abrasive force was applied.The ptfe coating was peeled off.(cause of occurrence) based on the investigation result, no anomaly was found in the manufacturing history record and dimensions.As a possible cause of occurrence, following factors were inferred.However, since the details of procedure were unknown, it was not possible to clarify the cause of stuck and the involved hard object.[bend] the distal end of actual device got stuck on some hard object and was dented.When the removal operation was performed in that state, abrasive force was applied at the stuck section, causing the distal end to bend.[peeling of ptfe coating] the removal operation was performed while the actual device was bent and in strong contact with some hard object (e.G., metal), causing it to peel off.(countermeasure) 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 in the appearance.In the shipping inspection, visual inspection is performed for each lot# to confirm that there is no anomaly in the appearance.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.Do not use the glidewire advantage with device which contain metal parts such as atherectomy catheters, laser catheters, or metal introduction devices as they may cause the glidewire advantage plastic coating to shear and/or sever the wire.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: 21638951
• Report Number: 9681834-2025-00044
• Device Sequence Number: 6687353
• Product Code: DQX
• UDI-Device Identifier: 04987350717924
• UDI-Public: (01)04987350717924(17)260630(10)240711
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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: 06/30/2026
• Device Model Number: GA1430
• Device Catalogue Number: RA*FA14301C
• Device Lot Number: 240711Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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 Sex: Unknown