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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the radifocus wire broke off in patient.The broken wire was retrieved from patient and there was no harm to patient.There was no patient injury, medical/surgical intervention required.The patient's condition was good.The procedure outcome was a success.Additional information was received on 22feb2021.The procedure being performed for the patient when the wire breakage occurred was a right lower extremity diagnostic angiogram; bypass graft superficial femoral artery to posterior tibial artery.They were able to retrieve the wire during the procedure.The patient's condition was stable.

• Brand Name: RADIFOCUS GLIDEWIRE ADVANTAGE TRACK
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 11385864
• Report Number: 2243441-2021-00007
• Device Sequence Number: 11771597
• Product Code: DQX
• UDI-Device Identifier: 04987350727848
• UDI-Public: 04987350727848
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 02/26/2021
• Report Date (Section F): 02/26/2021

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: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: GAT1830
• Device Lot Number: 200305
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/09/2021
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2021
• 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: NAVICROSS CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 35
• Date Report Sent to FDA: 02/26/2021