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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the glidewire severed in half as the doctor was spinning the wire thru a tight lesion.He was able to snare the wire without causing harm to the patient.The patient was stable.The procedure was successful, however was a prolonged case.Additional information was received on 16december 2021: the procedure was an aortogram, pelvic angiogram, and left superficial femoral artery (l sfa) with lithotripsy and self-expanding stent placement.Additional information was received on 17december 2021: no fragment was left in the patient.The doctor only had to snare the wire to remove it.It is unknown if there was any other equipment or devices used.

• 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: 13196485
• Report Number: 2243441-2021-00068
• Device Sequence Number: 20345310
• Product Code: DQX
• UDI-Device Identifier: 04987350773678
• UDI-Public: 04987350773678
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/07/2022
• Report Date (Section F): 01/07/2022

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: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: GS3510
• Device Lot Number: 210416
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/14/2021
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2022
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/07/2022