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	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the glidewire was used during the procedure; the doctor removed the wire and a piece of the coating was missing.The patient's condition was stable.There was no patient injury, medical/surgical intervention required.The procedure outcome was reported to be unknown.Additional information was received on 24may2021.The type of procedure being performed was a pm.It was unknown where on the wire that the coating was missing.Fluoroscopy was performed and confirmed the missing piece of the coating was left in the patient.The estimated blood loss was greater than 25 ml.Additional information was received on 25may2021.The missing piece was not removed.

• 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: 12024907
• Report Number: 2243441-2021-00028
• Device Sequence Number: 14541414
• Product Code: DQX
• UDI-Device Identifier: 04987350778376
• UDI-Public: 04987350778376
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/18/2021
• Report Date (Section F): 06/18/2021

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 Model Number: N/A
• Device Catalogue Number: GR3513
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2021
• 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
• Date Report Sent to FDA: 06/18/2021