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 2018-11-29 for CORPATH GRX SYSTEM 304 manufactured by Corindus, Inc..
[129339021]
The device was not returned. As such, no evaluation could be conducted. Review of the manufacturing records did not indicate any issues with the support track. If the guide catheter prolapses out of the support track, it is possible that the guide catheter could kink and become damaged. However as this case was completed successfully using the same guide catheter, it is indicated that the issue was detected by the user before damage could occur. It is likely that the lack of support of the guide catheter in this instance was due to a set-up issue by the user.
Patient Sequence No: 1, Text Type: N, H10
[129339022]
While manipulating the guide catheter from the control console, the cath lab technician saw the guide catheter prolapse thru the guide support track at the sheath. The cath lab technician pressed the exchange guide button and resupported the guide catheter. After this, the case was finished with the same guide catheter without incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007822508-2018-00009 |
| MDR Report Key | 8115452 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-29 |
| Date of Report | 2018-11-29 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2018-11-15 |
| Device Manufacturer Date | 2018-08-01 |
| Date Added to Maude | 2018-11-29 |
| 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 CASSETTE |
| Product Code | DXX |
| Date Received | 2018-11-29 |
| Catalog Number | 304 |
| Lot Number | 24H2018 |
| 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 | 2018-11-29 |