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

Model Number	NC35901
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the doctor experienced a malfunction with the involved navicross catheter, where the radio-opaque marker slipped off while in the patient.The marker, which resembles a ring, remains in the patient.The type of procedure performed was an ir process.There was no reported blood loss.Medical/surgical intervention was not required.Additional information was received on 14 nov 2024: the sample is contaminated by blood/body fluid but is not contaminated by infectious agents or anti-cancer agents.

• Brand Name: NAVICROSS
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 20701166
• Report Number: 2243441-2024-00037
• Device Sequence Number: 17764553
• Product Code: DQY
• UDI-Device Identifier: 04987350709189
• UDI-Public: (01)04987350709189(17)270430(10)240507
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/16/2024
• Report Date (Section F): 11/16/2024

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 Model Number: NC35901
• Device Catalogue Number: WS*NA35093H
• Device Lot Number: 240507
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/17/2024
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2024
• 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: 11/16/2024