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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the when the glidewire involved was used, it was spun, and the wire broke at that moment.The patient was in stable condition.The sheath was used inside a trailblazer.There was no patient injury/medical or surgical intervention required.The procedure was stopped.The estimated blood loss was less than 250cc's.Additional information was received on 18jan2023: the procedure performed when the issue occurred was an angiogram.The angiogram was performed prior to the procedure.There were no difficulties with arterial access, sheath, guidewire, or catheter insertion.There was no tortuosity noted in the patient's anatomy.Approximately 300 mm of the device broke off.The issue resolved for the patient by being aspirated on the trailblazer catheter and removed from the sheath.The broken wire was removed from the patient.Additional information was received on 27jan2023: the wire broke when it was inserted and manipulated inside the patient's body.

• Brand Name: GLIDEWIRE GT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 16286923
• Report Number: 2243441-2023-00005
• Device Sequence Number: 20023033
• Product Code: DQX
• UDI-Device Identifier: 04987350734808
• UDI-Public: 04987350734808
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2023
• Report Date (Section F): 02/02/2023

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: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: RG*GA1818SP
• Device Lot Number: 220628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/09/2023
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2023
• 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: TRAILBAZER.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/02/2023