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 2018-11-09 for CORPATH GRX SYSTEM 304 manufactured by Corindus, Inc..
[128038247]
According to the operator's manual, the user is supposed to conduct all movement of the interventional devices under fluoroscopy guidance, as it is a known risk that the guide catheter might kink if the user pushes with a great force while the tip of the guide catheter is not moving within the patient. The likely cause of this issue is that the high calcification in the patient caused a blockage that did not allow the guide catheter to pass. As the physician continued to actuate the guide catheter forward using the control console, it caused the guide catheter to kink. If the user was monitoring the fluoroscopy while advancing the guide catheter, they would have noticed that the guide catheter was not moving within the vessel and should have stopped actuation of the system before the guide catheter kinked.
Patient Sequence No: 1, Text Type: N, H10
[128038248]
The patient had a highly calcified lesion and poor guide support. When attempting to move the guide catheter forward using the corpath grx system, the guide catheter kinked, which also prompted a system error. The case was converted from a robotic procedure to a manual procedure, however it was still unable to be completed due to the calcification.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007822508-2018-00008 |
| MDR Report Key | 8055503 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-09 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2018-10-17 |
| Device Manufacturer Date | 2018-02-01 |
| Date Added to Maude | 2018-11-09 |
| 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 | 3 |
| Brand Name | CORPATH GRX SYSTEM |
| Generic Name | CORPATH GRX SYSTEM |
| Product Code | DXX |
| Date Received | 2018-11-09 |
| Catalog Number | 304 |
| Lot Number | 35B2018 |
| Device Expiration Date | 2019-01-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-11-09 |