MAUDE Adverse Event Report: CORINDUS, INC. CORPATH GRX SYSTEM

Catalog Number	304
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the operator's manual, the user is supposed to conduct all movement of the interventional devices under fluoroscopy guidance, as it is a known risk that the guide catheter might kink if the user pushes with a great force while the tip of the guide catheter is not moving within the patient.The likely cause of this issue is that the high calcification in the patient caused a blockage that did not allow the guide catheter to pass.As the physician continued to actuate the guide catheter forward using the control console, it caused the guide catheter to kink.If the user was monitoring the fluoroscopy while advancing the guide catheter, they would have noticed that the guide catheter was not moving within the vessel and should have stopped actuation of the system before the guide catheter kinked.
Event or Problem Description
The patient had a highly calcified lesion and poor guide support.When attempting to move the guide catheter forward using the corpath grx system, the guide catheter kinked, which also prompted a system error.The case was converted from a robotic procedure to a manual procedure, however it was still unable to be completed due to the calcification.

• Brand Name: CORPATH GRX SYSTEM
• Common Device Name: CORPATH GRX SYSTEM
• Manufacturer (Section D): CORINDUS, INC.; 309 waverley oaks road; suite 105; waltham MA 02452
• MDR Report Key: 8055503
• Report Number: 3007822508-2018-00008
• Device Sequence Number: 1539717
• Product Code: DXX
• UDI-Device Identifier: 00816280023048
• UDI-Public: (01)00816280023048(10)35B2018(17)190131
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 304
• Device Lot Number: 35B2018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1