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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the tc-wire device was used through an angiographic catheter.The patient complained of sharp pain and the wire was removed and inspected.Upon inspection the physician found that a portion of the wire was broken.Additional information was received on 29 jun 2022: the procedure taking place for the patient when the event occurred was a venogram procedure.The break was at the distal tip.The fragment was not isolated or removed from the patient.The fragment was unable to be located.The fragment was approximately 0.5cm.The patient was referred to a surgeon for evaluation.The patient is in stable condition.The procedure was successful as intended.The wire was used with a straight angiographic catheter.Additional information was received on 30 jun 2022: surgical intervention was not necessary at this time for the patient.

• Brand Name: RADIFOCUS GLIDEWIRE ADVANTAGE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 15094836
• Report Number: 2243441-2022-00019
• Device Sequence Number: 14783059
• Product Code: DQX
• UDI-Device Identifier: 04987350773159
• UDI-Public: 04987350773159
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/25/2022
• Report Date (Section F): 07/25/2022

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: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: GR3509
• Device Lot Number: 210622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2022
• 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: 07/25/2022