MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION NAVICROSS; CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the doctor was performing an intervention in the patient.He ballooned and pulled back then went down the at.The navicross was used in conjunction with a v18.At that point the distal tip of the navicross broke off and wedged in a side branch.The doctor decided not to risk retrieving it as there was still flow to the foot.There was no injury to the patient.Their hypothesis was that the navicross hit a piece of calcium upon pulling back.Type of procedure performed was a catheterization.Additional information was received on 15mar2024: the broken piece is still in the patient.Additional information was received on 19mar2024: other than the reported issue it was a straightforward case.

• Brand Name: NAVICROSS
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 19102831
• Report Number: 2243441-2024-00008
• Device Sequence Number: 15305681
• Product Code: DQY
• UDI-Device Identifier: 04987892077319
• UDI-Public: 04987892077319
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/13/2024
• Report Date (Section F): 04/13/2024

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: 11/30/2025
• Device Model Number: N/A
• Device Catalogue Number: NC18151
• Device Lot Number: 221212
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/14/2024
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2024
• 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: 04/13/2024