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

Model Number	GM1833
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the distal tip of the guidewire (gw) gold broke off while advancing the wire in a calcified stent in the femoral artery.A cook guiding sheath and catheter were used to advance the gold wire into the occlusion located in the lumen of a previously implanted stent.The patient was ok, and the procedure outcome was successful.Additional information was received on 30november2021.The tip was not removed.They are bringing the patient back for a bypass surgery, however, they felt as though the tip was secured in the calcification of the stent.

• Brand Name: RADIFOCUS GLIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 13095701
• Report Number: 2243441-2021-00064
• Device Sequence Number: 19882064
• Product Code: DQX
• UDI-Device Identifier: 04987350712165
• UDI-Public: 04987350712165
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 12/28/2021
• Report Date (Section F): 12/28/2021

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: 10/31/2022
• Device Model Number: GM1833
• Device Catalogue Number: GM1833
• Device Lot Number: 201117
• 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: 11/29/2021
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2021
• 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: 180CM .018 GT WIRE; COOK CATHETER; COOK GUIDING SHEATH
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/28/2021