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
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- nurse clinician.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and the shipping inspection record of the invovled product code/lot# combination was conducted with no findings.Please see mdr 2243441-2021-00009 for the importer report.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
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.
Additional Manufacturer Narrative
This reported event has been deemed not reportable based off the investigation of the actual device; inspection of the returned sample upon receipt found that the device had no breakage.The device involved in this complaint has been verified to be of normal product; therefore, is not a reportable event.

• 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: 11518532
• Report Number: 9681834-2021-00029
• Device Sequence Number: 4140276
• Product Code: DQY
• UDI-Device Identifier: 04987892077272
• UDI-Public: 04987892077272
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 04/18/2021
• 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: V14 WIRE
• Outcome Attributed to Adverse Event: Other