MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-11-19 for CORPATH 200 SYSTEM 160-00043 manufactured by Corindus, Inc..
[128038401]
The actual device was not returned. However, review of log files from the device indicated that the joystick was being activated as soon as the device was enabled. As such it appears that the joystick failed in a way that it was left in a constantly on position. It is possible that the drape used to cover the device may have been pulled too tight by the user, incidentally pushing the joystick into the "on" position. Since the device was not returned, it is not possible to deduce what might have caused this failure, yet in discussions with the distributor, the system is currently working as intended which indicates it as the user issue to be the most likely scenario.
Patient Sequence No: 1, Text Type: N, H10
[128038402]
The user reported that after loading a guidewire into the cassette and pressing the "enable" button on the control console that the guidewire started moving forward without the user activating the joystick. The emergency stop button had to be pressed to stop the guidewire from moving. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007822508-2018-00007 |
| MDR Report Key | 8086210 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-10-23 |
| Date Mfgr Received | 2018-10-23 |
| Date Added to Maude | 2018-11-19 |
| 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 | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORPATH 200 SYSTEM |
| Generic Name | CORPATH 200 SYSTEM |
| Product Code | DXX |
| Date Received | 2018-11-19 |
| Model Number | 160-00043 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-11-19 |