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

Model Number	NC35901
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported the catheter sheared off while in use, they were able to retrieve all pieces and cases was aborted.The procedure type was peripheral arterial disease (pad).The patient's condition was not applicable.No relevant tests were conducted.There was no blood loss.There was no injury described, and there was no direct allegation.The event occurred intra-operative.Additional information was recevied on 14 nov 2024: the sample is not contaminated by anti-cancer agent.

• Brand Name: GLIDECATH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 20803222
• Report Number: 2243441-2024-00041
• Device Sequence Number: 15800685
• Product Code: DQO
• UDI-Device Identifier: 04987350772237
• UDI-Public: (01)04987350772237(17)260731(10)230801
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/27/2024
• Report Date (Section F): 11/27/2024

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: 07/31/2026
• Device Model Number: NC35901
• Device Catalogue Number: CG417
• Device Lot Number: 230801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/28/2024
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2024
• 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: AMPLATZ WIRE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/27/2024