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

Catalog Number 304

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the system determined that the system was operating as intended at the time of the incident.Per discussion with the personnel involved, the bedside user lifted or held the guidewire during a guidewire rotation move.As such, this caused the guidewire to dislodge from the drive track.This error has the possibility of causing unintentional damage to the guidewire.The user was able to quickly recognize their error as they were able to un-wrap the guidewire and continue with the case.No patient complications were reported as part of this issue.

Event Description

Accorinding to the reporter, the guidewire wrapped around the rotary drive of the cassette while the physician was trying to cross the lesion.The issue was able to be corrected by the tech during the case and the case continued and completed successfully without any patient issues or complications.

• Brand Name: CORPATH GRX SYSTEM
• Type of Device: CORPATH GRX 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 waverley oaks road; suite 105; waltham, MA 02452 ; 5086533335
• MDR Report Key: 9610823
• MDR Text Key: 200670449
• Report Number: 3007822508-2020-00001
• Device Sequence Number: 1
• Product Code: DXX
• UDI-Device Identifier: 0816280023048
• UDI-Public: (01)0816280023048(10)55H2019(17)200731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 304
• Device Lot Number: 55H2019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1