MAUDE Adverse Event Report: CORINDUS, INC. CORPATH 200 SYSTEM

Catalog Number 160-00173-NC

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/05/2014

Event Type  malfunction  

Manufacturer Narrative

Discussion with the physician indicates that a linear pinch drive error occured during the procedure.It is believed that the cassette was opened before the user completed the full unlock procedure, which would have caused the linear pinch drive error.In addition, failing to complete the full unlock procedure could be an explanation for why the guidewire was stuck within the cassette.

Event Description

The physician was attempting to remove the wire from the cassette in order to manually continue the case, as the patient was in distress.The wire was unable to be removed from the cassette and was therefore stuck in the patient.The physician had to manually remove the device from the patient, and open and insert another wire to continue the case.No patient injury was reported.

• Brand Name: CORPATH 200 SYSTEM
• Type of Device: CORPATH 200 SYSTEM
• Manufacturer (Section D): CORINDUS, INC.; 309 waverley oaks road; suite 105; waltham MA 02452
• Manufacturer (Section G): CORINDUS, INC.; 309 waverley oaks road; suite 105; waltham MA 02452
• Manufacturer Contact: robert lavado ; 309 waveley oaks road; suite 105; waltham, MA 02452 ; 5086533335
• MDR Report Key: 6197971
• MDR Text Key: 63551941
• Report Number: 3007822508-2016-00024
• Device Sequence Number: 1
• Product Code: DXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 160-00173-NC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention