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

Model Number	GS3509
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the distal portion of the wire had its hydrophilic coating shear off.This resulted in catheters being unable to pass over it and caused the physician to lose wire access.The type of procedure performed was a leg angiogram.The patient's condition was stable.The estimated blood loss was less than 250cc.The event occurred intra-operative.Additional information was received on 28 may 2025: the sample is contaminated with blood but not with infectious agents or anti-cancer agents.The reported event did not result in patient injury or require medical or surgical intervention.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e3: occupation: facility admin.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.A historical investigation of the product with the involved product code and lot number revealed no anomalies in the manufacturing record or the shipping inspection record.Additionally, no other similar reports were found in the past complaint file.Please refer to section h10 for the importer's report on the reported event.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).
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9 and section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.Upon receipt, the actual device was identified as a guidewire.Visual inspection revealed that the wire had been exposed, and the outer layer was flared in two sections located approximately 1425mm to 1486mm from the distal end.Microscopic inspection of the guidewire revealed that both edges of the outer layer had been fractured and elongated.Streak marks were observed on each exposed wire.The outer layer was flared approximately 20mm.The wire was exposed for approximately 20mm.In section d, the outer layer was flared approximately 3mm, and in section e, the wire was exposed approximately 3mm.No anomalies, such as scratches, were observed in other sections of the device.Confirmation of dimensions indicated that the outer diameter at the normal sections of the guidewire met the factory's specifications.No anomalies were observed.Confirmation of the missing length indicated that the flared sections on the outer layer measured approximately 23mm in total, and the exposed sections on the wire also measured approximately 23mm in total.Since the lengths of the flared outer layer and the exposed wire matched, it is likely that no portion of the outer layer is missing.A history investigation was conducted for the product associated with the involved product code and lot number.No anomalies were identified in the manufacturing record or the shipping inspection record.Additionally, no other similar reports have been found in the past.A simulation test was conducted by performing pushing and pulling operations using both metal and resin torque devices fastened to each guidewire.As a result, the wire was exposed, and streak marks were observed on each exposed section.The outer layer was also found to be fractured and elongated.These conditions were considered likely to be similar to those observed on the actual device.Based on the investigation results, no anomalies were identified in the manufacturing history record or in the dimensions of the actual device.Considering the condition of the actual device and the results of the simulation test, a possible cause of the occurrence is that pushing and pulling operations were performed with either a metal or resin torque device fastened to the guidewire.This likely resulted in the outer layer becoming fractured, elongated, and flared.Additionally, since the length of the flared outer layer and the exposed wire matched, it is likely that no portion of the outer layer is missing.The ashitaka factory's manufacturing process assures the quality of this product through specific procedures and inspections.Each guidewire is passed through a dedicated tool on a 100% basis to confirm that there is no peeling of the outer layer and no adhesion of foreign substances on the surface.Prior to the packaging process, a 100% visual inspection is performed to ensure that there is no peeling of the outer layer on the surface of the guidewire.The ifu of this product includes the following precaution and warning.· do not use a metal torque device with the glidewire.Use of a metal torque device may result in damage to the wire.Also, do not slip a tightened-up torque device 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 glidewire and/or the catheter and determine the cause by fluoroscopy.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: 22298677
• Report Number: 9681834-2025-00106
• Device Sequence Number: 9227707
• Product Code: DQX
• UDI-Device Identifier: 04987350773654
• UDI-Public: (01)04987350773654(17)260630(10)240722
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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: GS3509
• Device Catalogue Number: RF*PA35263A
• Device Lot Number: 240722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• 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: Required Intervention
• Patient Sex: Unknown