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 160-00173-NC manufactured by Corindus, Inc..
[63551941]
Discussion with the physician indicates that a linear pinch drive error occured during the procedure. It is believed that the cassette was opened before the user completed the full unlock procedure, which would have caused the linear pinch drive error. In addition, failing to complete the full unlock procedure could be an explanation for why the guidewire was stuck within the cassette.
Patient Sequence No: 1, Text Type: N, H10
[63551942]
The physician was attempting to remove the wire from the cassette in order to manually continue the case, as the patient was in distress. The wire was unable to be removed from the cassette and was therefore stuck in the patient. The physician had to manually remove the device from the patient, and open and insert another wire to continue the case. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007822508-2016-00024 |
| MDR Report Key | 6197971 |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-21 |
| Date of Event | 2014-08-05 |
| Date Mfgr Received | 2014-07-31 |
| 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 WAVELEY 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 |
| Catalog Number | 160-00173-NC |
| 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 | 1. Required No Informationntervention | 2016-12-22 |