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

Model Number	NC35131
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the metal radiopaque marker from the device was stuck on the patient's tavr valve strut and got dislodged from the catheter when removed.The marker floated away from the initial position and ended up lodged in the distal portion of the circumflex coronary artery.Immediate actions reported was a left heart cauterization (lhc) performed to identify the area where it is was lodged and possible complications department reviewer comments / actions patient was having a paravalvular leak closure procedure and during the case, a catheter marker from a navicross catheter dislodged.A left heart catheterization was performed to check for position of dislodged part on fluoroscopy.The marker was noted to be lodged in the distal circumflex and in stable position with no current harm at the time and good blood flow was noted.The patient was stable during the procedure and transferred out of hybrid operating room (or) to post-anesthesia care unit (pacu) in stable condition after successful pvl closure procedure.The marker ended up in the carotid of the patient.They were able to get the marker and save the patient.No blood loss was reported.

• Brand Name: NAVICROSS
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomya city, 418 ; JA 418
• MDR Report Key: 20397661
• Report Number: 2243441-2024-00029
• Device Sequence Number: 19706265
• Product Code: DQY
• UDI-Device Identifier: 04987350709202
• UDI-Public: (01)04987350709202(17)270331(10)240423
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/08/2024
• Report Date (Section F): 10/08/2024

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: NC35131
• Device Catalogue Number: WS*NA350N3H
• Device Lot Number: 240423
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/20/2024
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• 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: GUIDEWIRES; SHEATHS
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/08/2024