MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDEWIRE; 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	04/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that when torquing the involved guidewire (gw), the distal angled portion of the gw broke off and remained in the patient.There was no blood loss.The reported event resulted in patient injury and/or require medical or surgical intervention.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.Additional information was received on 16apr2024: the procedure performed was a bilateral pelvic angiogram.There was no intervention performed when the wire broke off, the physician was attempting to cross a lesion.There was no more resistance than what was to be expected.The broken piece was not removed from the patient, it was in the retroperitoneal soft tissue.The piece remained in the patient.The patient was stable.The procedure was not completed at that time due to patient tolerance.The patient needed anesthesia and the procedure was completed a different day with general anesthesia.The device did not appear to be damaged prior to use.

• Brand Name: RADIFOCUS GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 19220780
• Report Number: 2243441-2024-00010
• Device Sequence Number: 20881632
• Product Code: DQX
• UDI-Device Identifier: 04987350773593
• UDI-Public: 04987350773593
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2024
• Report Date (Section F): 05/01/2024

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: 10/31/2025
• Device Model Number: N/A
• Device Catalogue Number: GS3506
• Device Lot Number: 231117
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/09/2024
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2024
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/01/2024