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	Foreign Body In Patient (2687)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the doctor was attempting to cross a very calcified occluded pedal loop when they removed the wire it unraveled, and they noted that the tip of the wire was still in the patient.It was left between the first and second toe.The patient was stable, and the procedure outcome was a success.The estimated blood loss was less than 250cc.Additional information was received on 03-december-2021: the procedure was a left lower extremity angiogram with intervention.The wire was still in the patients left foot between their first and second toe.
Event or Problem Description
The user facility reported that the doctor was attempting to cross a very calcified occluded pedal loop when they removed the wire it unraveled, and they noted that the tip of the wire was still in the patient.It was left between the first and second toe.The patient was stable, and the procedure outcome was a success.The estimated blood loss was less than 250cc.Additional information was received on 03-december-2021: the procedure was a left lower extremity angiogram with intervention.The wire was still in the patients left foot between their first and second toe.

• 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: 13112881
• Report Number: 2243441-2021-00065
• Device Sequence Number: 3537567
• Product Code: DQX
• UDI-Device Identifier: 04987350727886
• UDI-Public: 04987350727886
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 12/29/2021
• Report Date (Section F): 12/29/2021

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: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: GAT1430
• Device Lot Number: 200710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/25/2021
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2021
• 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: .018 NAVICROSS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 12/29/2021