MAUDE Adverse Event Report: CORINDUS INC CORPATH GRX; CORPATH GRX SYSTEM

Model Number	301
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
After 1st stent placement an kb inflation (crux cords) proximal to the stent in 3rd seg.Of rca flow limiting dissection appeared.The attempt to robotically deliver the stent to cover it or balloon to do additional lesion preparation failed.Due to clinical condition (chest pain and ecg changes) decision was to switch to manual.After successful 2nd stent implantation and clinical stabilization 3rd stent and final ballooning done once more robotically.
Additional Manufacturer Narrative
Incident reported to the manufacturer on 8/27/2021.There was no problem with the device during the procedure and the procedure was completed.The event was not device related and is a known risk of pci procedures.The device functioned as it was intended to and there was no problem with the way device was used.

• Brand Name: CORPATH GRX
• Common Device Name: CORPATH GRX SYSTEM
• Manufacturer (Section D): CORINDUS INC; 309 waverly oaks road; waltham MA 02452
• MDR Report Key: 12509398
• Report Number: 3007822508-2021-00003
• Device Sequence Number: 14742278
• Product Code: DXX
• UDI-Device Identifier: 00816280023017
• UDI-Public: 00816280023017
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K173806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 301
• Device Catalogue Number: 301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1