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
Additional Manufacturer Narrative
A3b: gender: unknown.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: tech.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.1.History investigation of the involved product code/lot#.No anomaly was found in the manufacturing record and the shipping inspection record.No other similar event was found in the past complaint file.For the past three years, no cases of product fracture caused by defects attributable to manufacturing was found.2.Udi no: (b)(4).Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).For the importer report for this reported event please see mdr 2243441-2024-00008.
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
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 19102828
• Report Number: 9681834-2024-00058
• Device Sequence Number: 17994140
• Product Code: DQY
• UDI-Device Identifier: 04987892077319
• UDI-Public: 04987892077319
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K173799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Initial Report FDA Received Date: 04/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown