MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-22 for CORPATH 200 SYSTEM 160-00043 manufactured by Corindus, Inc..
[63499562]
The joystick manufacturing process was evaluated and updated to prevent future occurences of this issue.
Patient Sequence No: 1, Text Type: N, H10
[63499563]
The joystick was observed to be "twisted" to the extent that the rubber cowl at the base was "crumpled-up" upon itself. When the joystick was in this condition, there was a tendency for the joystick to not return to its home position. This resulted in the guidewire moving very slowly when it has not be properly actuated. There was no patient injury reported, however unintended guidewire motion has the potential to cause vessel injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007822508-2016-00023 |
| MDR Report Key | 6197973 |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-21 |
| Date of Event | 2013-06-27 |
| Date Mfgr Received | 2013-06-27 |
| Date Added to Maude | 2016-12-22 |
| 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 | 0 |
| Brand Name | CORPATH 200 SYSTEM |
| Generic Name | CORPATH 200 SYSTEM |
| Product Code | DXX |
| Date Received | 2016-12-22 |
| Returned To Mfg | 2013-07-09 |
| Model Number | 160-00043 |
| 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 | 2016-12-22 |