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
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
• MDR Report Key: 17742149
• Report Number: 2243441-2023-00030
• Device Sequence Number: 5282007
• Product Code: DQY
• UDI-Device Identifier: 04987892077272
• UDI-Public: 04987892077272
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/13/2023
• Report Date (Section F): 07/18/2023

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/17/2023
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2023
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/18/2023