MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GLIDECATH CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the glidecath device involved sheared off inside the patient due to severe calcium deposits.The piece was retrieved with a snare and the patient was unaffected.There patient condition was fine.The procedure outcome was fine.There was no patient injury/surgical intervention required.Additional information was received on 29 mar 2022: the procedure performed was a thromboendoarterectomy femoral artery and abd aortography.

• Brand Name: RADIFOCUS GLIDECATH CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 13998495
• Report Number: 2243441-2022-00009
• Device Sequence Number: 4865064
• Product Code: DQO
• UDI-Device Identifier: 04987350772138
• UDI-Public: 04987350772138
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): 04/04/2022
• Report Date (Section F): 04/04/2022

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 Model Number: N/A
• Device Catalogue Number: CG412
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2022
• 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: SNARE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/04/2022