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

Catalog Number	304
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not 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 of the support track, it is possible that the guide catheter could kink and become damaged.However as this case was completed successfully using the same guide catheter, it is indicated that the issue was detected by the user before damage could occur.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, the cath lab technician saw the guide catheter prolapse thru the guide support track at the sheath.The cath lab technician pressed the exchange guide button and resupported the guide catheter.After this, the case was finished with the same guide catheter without incident.

• Brand Name: CORPATH GRX SYSTEM
• Common Device Name: CORPATH GRX CASSETTE
• Manufacturer (Section D): CORINDUS, INC.; 309 waverley oaks road; suite 105; waltham MA 02452
• MDR Report Key: 8115452
• Report Number: 3007822508-2018-00009
• Device Sequence Number: 10830126
• Product Code: DXX
• UDI-Device Identifier: 00816280023048
• UDI-Public: (01)00816280023048(10)24H2018(17)190731
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/29/2018

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: 07/31/2019
• Device Catalogue Number: 304
• Device Lot Number: 24H2018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1