MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M; WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the tip of glidewire broke off during case as they were trying to advance through calcified lesion.The estimated blood loss was unknown.They had to retrieve the tip of the wire.The patient was in stable condition.The procedure outcome was that they had to finish before done.Additional information was received on 20jul2023: the procedure being performed was a lower extremity angio.

• Brand Name: RADIFOCUS GUIDEWIRE OR GLIDEWIRE OR GLIDEWIRE M
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 18274841
• Report Number: 2243441-2023-00050
• Device Sequence Number: 3613419
• Product Code: DQX
• UDI-Device Identifier: 04987350773654
• UDI-Public: 04987350773654
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2023
• Report Date (Section F): 12/06/2023

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: 08/31/2024
• Device Model Number: N/A
• Device Catalogue Number: GS3509
• Device Lot Number: 220930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/13/2023
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 12/06/2023