MAUDE Adverse Event Report: CORINDUS INC CORPATH GRX SYSTEM

Model Number	301
Health Effect - Clinical Codes	Vertigo (2134); Movement Disorder (4412); Speech Disorder (4415); Paresthesia (4421)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no problem with the device during the procedure and the procedure was completed without any incident.The event occurred after the pci 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 device or the way it was used.
Event or Problem Description
After successful pci procedure patient complained of difficult speech and paresthesia on the left side of the face and tongue with decreased strength of right arm and vertigo.In brain ct on 5.08 there were no fresh focal lesion, only periventricular leucoaraiosis.On angio-ct probably old left common carotid occlusion which was not known previously.The site states that the event was not device related.

• Brand Name: CORPATH GRX SYSTEM
• Common Device Name: CORPATH GRX SYSTEM
• Manufacturer (Section D): CORINDUS INC; 309 waverly oaks road; waltham MA 02452
• MDR Report Key: 12392430
• Report Number: 3007822508-2021-00002
• Device Sequence Number: 11693926
• 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): 08/31/2021

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: 08/11/2021
• Initial Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other