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

Model Number	301
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.As such, no evaluation could be conducted.Review of the manufacturing records did not indicate any issues with the support track.If the guide catheter prolapses out fo the support track, it is possible that the guide catheter could kink and become damaged.It is likely that the lack of support of the guide catheter in this instance was due to a set-up issue by the user.
Event or Problem Description
While manipulating the guide catheter from the control console, it was observed that the guide catheter prolapsed at the sheath hub.The case was converted from a robotic to a manual procedure.The case was completed successfully without any patient complications.

• 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: 9281522
• Report Number: 3007822508-2019-00010
• Device Sequence Number: 10865403
• Product Code: DXX
• UDI-Device Identifier: 00816280023017
• UDI-Public: (01)00816280023017(11)190606
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K180517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2019

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: No Information
• Device Model Number: 301
• Device Catalogue Number: 301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1