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

Model Number	GAT1418
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided due to hospital policy.A2: age & date of birth: requested, not provided due to hospital policy.A3a: sex: requested, not provided due to hospital policy.A4: weight: requested, not provided due to hospital policy.A5: ethnicity: requested, not provided due to hospital policy.A6: race: requested, not provided due to hospital policy.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).Please refer to section h10 for the importer report on the reported event.
Event or Problem Description
The user facility reported that they had a deep vein thrombosis (dvt) procedure.They attempted to cross the cap of the lesion however, the wire got stuck in the webbing and broke off in the patient.The wire is in a stable position and will not need to be removed.There was no blood loss additional information was received on 26mar2025: the broken piece of the wire is approximately 1-3cm long.The patient was stable, and the procedure was successful.They do not want to try removing that part of the wire since it's in a safe, fibrotic location.
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.Although the product code in the ppr was ra*gb14181c (radifocus glidewire advantage track 0.014"), the actual device upon receipt was a radifocus glidewire advantage 0.035".Therefore, we investigated (b)(4) as "the product code and lot were unknown".In addition, since the product code was unknown, it was not possible to clarify the missing length.The exact product code and lot are currently under investigation.Visual and microscopic inspections - the distal end had been fractured.- it had been bent near the fractured section.- a torn shape was found in the fractured section of outer layer.- it had been abraded at approximately 375mm and 446mm from the fractured section.- there were intermittent abrasion marks in the longitudinal direction at approximately 782mm - 1047mm from the fractured section.- there were continuous abrasion marks in the longitudinal direction at approximately 1563mm - 1580mm from the fractured section.- no anomaly was found in other sections.Electron microscopic inspection: the outer layer at the fractured section was removed to expose the wire.- the side of wire at the fractured section had been curved and twisted.- dimple patterns (hole-shaped patterns) were found on the top surface of wire at the fractured section.Confirmation of dimensions: - outer diameters of the hydrophilic coating and ptfe coating at the normal sections met the factory's specifications of radifocus glidewire advantage 0.035".No anomaly was found.History investigation of the product with the involved product code/lot number - since the product code and lot were unknown, the manufacturing record and the shipping inspection record could not be investigated.- in the past three years, we have not received any similar complaints of radifocus glidewire advantage caused by the manufacturing process.Simulation test: [test method] made the distal end getting stuck, pulling and torque force were applied in a looped state.[test result] - the side of wire at the fractured section was curved and twisted.- dimple patterns (hole-shaped patterns) were found on the top surface of wire at the fractured section.- these conditions were likely to be similar to those of the actual device.Udi no.- since the product code and lot were unknown, it was not possible to investigate.(cause of occurrence): - based on the condition of actual device and the simulation test result, as a possible cause of getting stuck, following factors were inferred.However, since the details of procedure were unknown, it was not possible to clarify the cause of stuck.- the distal end of actual device got stuck for some factors.- when operating the actual device in that state, a loop was formed.- bending force caused by the loop was applied to the actual device, causing it to bend near the fractured section.- the actual device fractured when pulling and torque force were applied while it was in a looped state.Regarding the cause of abrasions and abrasion marks, it was likely that the actual device came into contact with some hard object.However, since the details of procedure were unknown, it was not possible to clarify the cause of occurrence.(countermeasure): - ashitaka factory has been making efforts in maintaining the quality of the product by performing following work and inspections.- before the packaging process, 100% visual inspection is performed to confirm that there is no anomaly in appearance.- the outer diameter of this product is controlled to confirm that there is no anomaly in it.- the length of outer layer at the distal end is measured to confirm that there is no missing.The 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.(b)(4) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Additional Manufacturer Narrative
This report is being sent as follow-up no.2 to update sections d4 and h3, and to provide the completed investigation results.The actual device was received by ashitaka factory on april 22, 2025.Although the product code in the ppr was ra*gb14181c (radifocus glidewire advantage track 0.014"), the actual device upon receipt was a radifocus glidewire advantage 0.035".On may 12, 2025, we inquired to tmc about the exact product code and lot.On may 15, 2025, the answer card issued as "the product code and lot were unknown".At that time, it was stated that "the exact product code and lot are currently under investigation".On june 20, 2025, as no additional information was available, we sent an email to tmc stating that "we will proceed with the matter without knowing the code number and lot number".Therefore, we answer (b)(4) mdr follow up as "the product code and lot were unknown".In addition, since the product code was unknown, it was not possible to clarify the missing length.Visual and microscopic inspections - the distal end had been fractured.- it had been bent near the fractured section.- a torn shape was found in the fractured section of outer layer.- it had been abraded at approximately 375mm and 446mm from the fractured section.- there were intermittent abrasion marks in the longitudinal direction at approximately 782mm - 1047mm from the fractured section.- there were continuous abrasion marks in the longitudinal direction at approximately 1563mm - 1580mm from the fractured section.- no anomaly was found in other sections.Electron microscopic inspection the outer layer at the fractured section was removed to expose the wire.- the side of wire at the fractured section had been curved and twisted.- dimple patterns (hole-shaped patterns) were found on the top surface of wire at the fractured section.Confirmation of dimensions - outer diameters of the hydrophilic coating and ptfe coating at the normal sections met the factory's specifications of radifocus glidewire advantage 0.035".No anomaly was found.History investigation of the product with the involved product code/lot number - since the product code and lot were unknown, the manufacturing record and the shipping inspection record could not be investigated.- in the past three years, we have not received any similar complaints of radifocus glidewire advantage caused by the manufacturing process.Simulation test [test method] - made the distal end getting stuck, pulling and torque force were applied in a looped state.[test result] - the side of wire at the fractured section was curved and twisted.- dimple patterns (hole-shaped patterns) were found on the top surface of wire at the fractured section.- these conditions were likely to be similar to those of the actual device.Udi no.- since the product code and lot were unknown, it was not possible to investigate.(cause of occurrence) based on the condition of actual device and the simulation test result, as a possible cause of getting stuck, following factors were inferred.However, since the details of procedure were unknown, it was not possible to clarify the cause of stuck.- the distal end of actual device got stuck for some factors.- when operating the actual device in that state, a loop was formed.- bending force caused by the loop was applied to the actual device, causing it to bend near the fractured section.- the actual device fractured when pulling and torque force were applied while it was in a looped state.Regarding the cause of abrasions and abrasion marks, it was likely that the actual device came into contact with some hard object.However, since the details of procedure were unknown, it was not possible to clarify the cause of occurrence.Countermeasure - ashitaka factory has been making efforts in maintaining the quality of the product by performing following work and inspections.- before the packaging process, 100% visual inspection is performed to confirm that there is no anomaly in appearance.- the outer diameter of this product is controlled to confirm that there is no anomaly in it.- the length of outer layer at the distal end is measured to confirm that there is no missing.The 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.

• Brand Name: GLIDEWIRE ADVANTAGE TRACK
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 21885032
• Report Number: 9681834-2025-00058
• Device Sequence Number: 20880431
• Product Code: DQX
• UDI-Device Identifier: 04987350727862
• UDI-Public: (01)04987350727862(17)260831(10)240906
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K163004
• 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,Followup
• Report Date (Section B): 04/22/2025

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: 08/31/2026
• Device Model Number: GAT1418
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 04/22/2025; 06/20/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/16/2025; 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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