MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA NAVICROSS 0.018"; CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the tip of the involved navicross broke off in the patient.Doctor stated that the patient was ok.The event occurred inta-operative.The procedure outcome was completed.The patient was not injured, and surgical intervention was not required.Additional information was received on 10 nov 2022: procedure taking place, when the tip of the navicross broke off inside the patient was pad below the knee case.The navicross broke off below the knee and were able to remove the navicross tip from the patient's anatomy.Surgical intervention was not required.There was no tortuous anatomy experienced during the procedure.The original procedure was completed as intended.

• Brand Name: NAVICROSS 0.018"
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 15867835
• Report Number: 2243441-2022-00030
• Device Sequence Number: 12437182
• Product Code: DQY
• UDI-Device Identifier: 04987892077319
• UDI-Public: 04987892077319
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2022
• Report Date (Section F): 11/28/2022

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: NC18151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/01/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2022
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/28/2022