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 2018-09-28 for CORPATH GRX SYSTEM 302 manufactured by Corindus, Inc..
[122014270]
A loose extended reach arm has the potential to cause unintended motion of the interventional devices. According to the user, the case was completed successfully with no patient complications and no unintended motion of interventional devices was noted. Corindus service went to the site to evaluate the unit and determined that the friction joint of the extended reach arm had loosened beyond acceptable specification. Service was conducted to the friction joint and return the extended reach arm to specification.
Patient Sequence No: 1, Text Type: N, H10
[122014271]
The user noted that the friction joint of the extended reach arm continued to move after positioning the arm. It was also stated that the extended reach arm drifted when pulling back the guide catheter support track.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007822508-2018-00006 |
| MDR Report Key | 7918144 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-28 |
| Date of Report | 2018-09-28 |
| Date of Event | 2018-09-09 |
| Date Mfgr Received | 2018-09-10 |
| Device Manufacturer Date | 2017-02-20 |
| Date Added to Maude | 2018-09-28 |
| 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 | 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 GRX SYSTEM |
| Generic Name | CORPATH GRX SYSTEM |
| Product Code | DXX |
| Date Received | 2018-09-28 |
| Model Number | 302 |
| Catalog Number | 302 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-09-28 |