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

Model Number	302
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A loose extended reach arm has the potential to cause unintended motion of the interventional devices.According to the user, the case was completed successfully with no patient complications and no unintended motion of interventional devices was noted.Corindus service went to the site to evaluate the unit and determined that the friction joint of the extended reach arm had loosened beyond acceptable specification.Service was conducted to the friction joint and return the extended reach arm to specification.
Event or Problem Description
The user noted that the friction joint of the extended reach arm continued to move after positioning the arm.It was also stated that the extended reach arm drifted when pulling back the guide catheter support track.

• 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: 7918144
• Report Number: 3007822508-2018-00006
• Device Sequence Number: 11275774
• Product Code: DXX
• UDI-Device Identifier: 00816280023024
• UDI-Public: (01)00816280023024(11)170220
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 09/28/2018

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 Model Number: 302
• Device Catalogue Number: 302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1