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

Model Number	NC18131
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during an angioplasty of the anterior tibial artery, a foreign body appeared at the tip of the navicross catheter.It appeared to come from either the navicross 18 or the v14 wire that was also used for the procedure.The foreign body was stented to the wall of the vessel without incident and the patient had a successful procedure.Upon initial examination with the naked eye, it was difficult to tell if there was any missing component to the tip of the navicross 18.The patient was in stable condition and was discharged.

• Brand Name: TERUMO NAVICROSS SUPPORT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 11518525
• Report Number: 2243441-2021-00009
• Device Sequence Number: 17094861
• Product Code: DQY
• UDI-Device Identifier: 04987892077272
• UDI-Public: 04987892077272
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/18/2021
• Report Date (Section F): 03/18/2021

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: 03/31/2023
• Device Model Number: NC18131
• Device Catalogue Number: NC18131
• Device Lot Number: 200414
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/22/2021
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2021
• 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
• Date Report Sent to FDA: 03/18/2021