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 2018-04-05 for CORPATH GRX SYSTEM 301 manufactured by Corindus, Inc..
[104811361]
An investigation was conducted where by the joystick was disassembled upon return. It ws discovered that the joystick had been over-torqued by the user. This over-torquing caused to potentiometer of the joystick to stay out of the dead band and as such, left the joystick in a position that an active voltage was constantly applied keeping the system in a driving mode while the operator was touching the joystick, even if the joystick position was in the dead band zone. Overall, this issue was caused by mis-use of the system.
Patient Sequence No: 1, Text Type: N, H10
[104811362]
While using the corpath grx system for a pci procedure, the physician attempted to advance the guidewire, he noted that the guidewire was responding more than usual. The joystick was moved to the first variable speed level, but the guidewire was moving faster than anticipated. The same issue occured when attempting to rotate the guidewire. Eventually an alarm and error sounded on the control console instructing to "release joystick. " the case was converted to a manual procedure and was successfully completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007822508-2018-00001 |
| MDR Report Key | 7400392 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-05 |
| Date of Report | 2018-04-03 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-03-13 |
| Device Manufacturer Date | 2017-09-22 |
| Date Added to Maude | 2018-04-05 |
| 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 GRX SYSTEM |
| Generic Name | CORPATH GRX SYSTEM |
| Product Code | DXX |
| Date Received | 2018-04-05 |
| Returned To Mfg | 2018-03-15 |
| Model Number | 301 |
| Catalog Number | 301 |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2018-04-05 |