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 2017-01-05 for CORPATH 200 SYSTEM 160-00043 manufactured by Corindus, Inc..
[64016282]
The guidewire joystick would not return to its neutral position for rotation and the guidewire continued to rotate without user actuation of the joystick. When the joystick was forced to return to its neutral position, the rotation actuation mechanism ceased to function.
Patient Sequence No: 1, Text Type: D, B5
[66799150]
The user over-torqued the joystick causing the shaft to break its adhesion within the joystick spindle. The torque on the spring pin within the cap caused its residing hole to deform, elongating the hole and making it unable to contain the pressed pin any further.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007822508-2016-00025 |
| MDR Report Key | 6227199 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-01-05 |
| Date of Report | 2017-02-01 |
| Date of Event | 2016-12-08 |
| Date Mfgr Received | 2016-12-09 |
| Date Added to Maude | 2017-01-05 |
| 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 200 SYSTEM |
| Generic Name | CORPATH 200 SYSTEM |
| Product Code | DXX |
| Date Received | 2017-01-05 |
| Returned To Mfg | 2016-12-21 |
| Catalog Number | 160-00043 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-01-05 |