MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA NAVICROSS 0.018"; CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.History investigation of the involved product code/lot # was conducted.No anomaly was found in the manufacturing record and the shipping inspection record.There was no other similar report in the past.Based on the investigation result, as for the involved product code/lot #, no deviations or nonconformities related to the involved event had occurred, and no other similar report from other facilities was found.In this case, since the actual sample was not returned, the cause of the occurrence could not be clarified.The instructions for use (ifu) has the following warning and directions for use: warnings and precautions: carefully handle the product under fluoroscopy.If any resistance is felt while handling the product, immediately stop the manipulation and find out the cause to avoid damage to blood vessels and separation or breakage of the product.Directions for use: advance the guide wire and the product to the target vessel under fluoroscopy.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
Terumo medical received an fda medwatch report # mw5119966.The event description stated that involved device catheter tip was impacted and detached from the catheter when the provider encountered significant amount of calcific disease.There was no harm to the patient.

• Brand Name: NAVICROSS 0.018"
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• 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 ; 6402040886
• MDR Report Key: 17742128
• Report Number: 9681834-2023-00178
• Device Sequence Number: 4184994
• Product Code: DQY
• UDI-Device Identifier: 04987892077272
• UDI-Public: 04987892077272
• Combination Product (Y/N): N
• 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: Other,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/13/2023

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: 04/04/2023
• Device Model Number: N/A
• Device Catalogue Number: NC18131
• Device Lot Number: 230404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2023
• 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