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

Model Number	NC*F863A
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that involved finecross device was stuck in left anterior descending vessel during complex percutaneous coronary intervention procedure.The patient was scheduled for a percutaneous coronary intervention after turning down coronary artery bypass graft a year ago.Diffusely calcified left anterior descending appreciated with fluoroscopy.The finecross was inserted, viperwire inserted through fc, then when trying to remove the finecross, the md noticed the marker was not moving.The md/staff were not pulling on the mc.They determined that approximately 15 cm were left in the patient; and were unable to snare the device.The procedure was reported to be unsuccessful.A left main dissection was also noted.The patient went to emergency surgery for coronary artery bypass graft.The patient was reported to be in the icu 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: 8935793
• Report Number: 2243441-2019-00078
• Device Sequence Number: 11262599
• Product Code: KRA
• UDI-Device Identifier: 04987350703163
• UDI-Public: 04987350703163
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2019
• Report Date (Section F): 08/27/2019

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: 03/31/2021
• Device Model Number: NC*F863A
• Device Catalogue Number: 35-1430
• Device Lot Number: 190409
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/12/2019
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2019
• 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: GUIDE CATH; GUIDEZILLA; RUNTHROUGH; SPRINTER 1.5MM AND 2.0MM BALLOONS; VIPER WIRE; WHISPER
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 08/27/2019