MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-07-24 for CORPATH GRX SYSTEM 301 manufactured by Corindus, Inc..
[114946422]
The system log files were returned to corindus for evaluation. The evaluation determined that a software communications timing issue occured during the procedure, which caused the system to become unresponsive. A software reboot of the system corrected the issue. The physician was still able to remove the devices from the patient using the emergency device release built into the cassette. As such, no patient injury or complications were reported and the case was able to be completed manually. This issue will continue to be monitored and trended for analysis.
Patient Sequence No: 1, Text Type: N, H10
[114946423]
The system became unresponsive when the physician attempted to pull back the support track to manually seat the guide catheter. As a result, the balloon catheter and guidewire were still engaged in the cassette and stuck within the patient. The emergency release button on the cassette was pressed and the cassette was disassembled to remove the trapped devices. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007822508-2018-00004 |
| MDR Report Key | 7713735 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-24 |
| Date of Report | 2018-07-24 |
| Date of Event | 2018-07-05 |
| Date Mfgr Received | 2018-07-06 |
| Device Manufacturer Date | 2018-01-09 |
| Date Added to Maude | 2018-07-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERT LAVADO |
| Manufacturer Street | 309 WAVERLEY OAKS ROAD SUITE 105 |
| Manufacturer City | WALTHAM MA 02452 |
| Manufacturer Country | US |
| Manufacturer Postal | 02452 |
| Manufacturer Phone | 5086533335 |
| Manufacturer G1 | CORINDUS, INC. |
| Manufacturer Street | 309 WAVERLEY OAKS ROAD SUITE 105 |
| Manufacturer City | WALTHAM MA 02452 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02452 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORPATH GRX SYSTEM |
| Generic Name | CORPATH GRX SYSTEM |
| Product Code | DXX |
| Date Received | 2018-07-24 |
| Model Number | 301 |
| Catalog Number | 301 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORINDUS, INC. |
| Manufacturer Address | 309 WAVERLEY OAKS ROAD SUITE 105 WALTHAM MA 02452 US 02452 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-24 |