MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA FINECROSS MG CORONARY MICRO-GUIDE CATHETER; CATHETER, CONTINUOUS FLUSH

Model Number	NC*F865A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the finecross device was successfully used to cross a heavily calcified sub-total occlusion.While retracting the finecross device at the end of the procedure the tip of the microcatheter broke and remained in the patient.The physician was not able to retrieve the broken tip.The procedure outcome was a success.There was no impact to the patient's health.The patient was in stable condition.

• Brand Name: FINECROSS MG CORONARY MICRO-GUIDE CATHETER
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10176700
• Report Number: 2243441-2020-00031
• Device Sequence Number: 19410627
• Product Code: KRA
• UDI-Device Identifier: 04987350703187
• UDI-Public: 04987350703187
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/19/2020
• Report Date (Section F): 06/19/2020

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: 06/30/2020
• Device Model Number: NC*F865A
• Device Catalogue Number: 35-1450
• Device Lot Number: 180724
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/25/2020
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/26/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2020
• 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: 06/19/2020