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
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.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.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.Please see mdr (b)(4) for the importer report.
Event or Problem Description
The user facility reported that involved fine cross 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 fine cross was inserted, viper wire inserted through fc, then when trying to remove the fine cross, 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.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d10, update section h3, and to provide the completed investigation results.H6 - results - 3211 is based upon evaluation of user facility information and the returned sample; 213 is based upon evaluation of the second returned sample.H6 - conclusion - 4310 is based upon evaluation of user facility information and the returned sample; 67 is based upon evaluation of the second returned sample.Two actual samples were received for evaluation.One of them was found with a fracture on the distal end (sample 1), and the other seemed intact over the total length (sample 2).Both samples were inspected.The total length of sample 1 was compared with that of a factory-retained sample of the involved product code.It was confirmed that distal 150mm was missing.Magnifying inspection around the fracture end found that distal 6mm had been elongated.The fracture end was found almost straight and no deformity in a tapered shape was noted.Electron microscopic inspection of the outer layer around the fracture end revealed that several longitudinal abrasions had been generated starting from the fracture end to approximately 40mm from the fracture end.The outer diameter was measured on the segment other than the elongated segment and confirmed to meet the specifications.The strength of the shaft against bending force was tested on the segment other than the elongated segment and confirmed to meet the specifications.Magnifying inspection of sample 2 did not find any visible anomaly, including a kink or elongation, over the total length.Reproductive testing was performed on two retention finecross mg samples of the involved product code.The distal end being trapped was exposed to pulling force in the proximal direction.The shaft became elongated and fractured at approximately 152mm from the distal end.The outside diameter of the shaft became diminished toward the fracture end.The state of damage was confirmed to be different from that on sample 1.The other test sample in the state of being trapped at approximately 150mm from the distal end was exposed to pulling force in the proximal direction.The shaft became elongated starting at the trapped point and fractured at the trapped point.The outside diameter of the shaft was not diminished.The state of damage was confirmed to be similar to that on sample 1.Ifu states: remove the product, the guide wire and the guiding catheter altogether if any resistance is felt while withdrawing the product.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that sample 1 became trapped by some hard object (e.G.Calcified lesion).During attempts to release the trap, pulling force was applied to sample 1.As a result, sample 1 became elongated starting from the trapped point, and fractured off finally.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• 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: 8935795
• Report Number: 9681834-2019-00155
• Device Sequence Number: 10894054
• Product Code: KRA
• UDI-Device Identifier: 04987350703163
• UDI-Public: 04987350703163
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K082519
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 10/04/2019
• 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