MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-11-28 for CORPATH GRX SYSTEM 301 manufactured by Corindus, Inc..
[93563021]
Issue resolved itself after a system shutdown and reboot. A subsequent procedure was completed using the same control console and the device functioned as intended. It has not been possible to recreate the issue. No further evaluation or conclusions can be reached.
Patient Sequence No: 1, Text Type: N, H10
[93563022]
After removing the pre-dilation balloon, the stent was placed in the cassette as would normally be done. At this time, the control console screen froze. The user tried pressing load/exchange guide, opening and closing the cassette covers and an e-stop restart to get the screen to unfreeze. The physician had to manually remove the guidewire and stent from the locked cassette and convert to a manual procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007822508-2017-00002 |
| MDR Report Key | 7065049 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-11-28 |
| Date of Report | 2017-11-28 |
| Date of Event | 2017-11-10 |
| Date Mfgr Received | 2017-11-10 |
| Date Added to Maude | 2017-11-28 |
| 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 |
| 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 | 2017-11-28 |
| Model Number | 301 |
| Catalog Number | 301 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-11-28 |