MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-10-18 for CORPATH GRX SYSTEM 304 manufactured by Corindus, Inc.
[90597037]
The indications for use of the corpath grx system are: "the corpath grx system is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (pci) procedures. " the novoste beta-cath device, while a rapid exchange catheter, is not a balloon/stent catheter and thus use of the beta-cath device with the corpath grx system is off-label. In addition, the corpath grx system is only intended for use during pci procedures, while the beta-cath system is indicated for use post-pci procedure for the treatment of in-stent restenosis. Further, the corpath grx system is designed for use with balloon/stent catheters with a poximal shaft diameter of less than or equal to 2. 7 fr. The beta-cath device has a proximal shaft diameter of 3. 5 fr, and is therefore incompatible with the corpath grx system.
Patient Sequence No: 1, Text Type: N, H10
[90597038]
The physician used the corpath grx system in an attempt to drive a beta-cath system for brach therapy. The beta-cath catheter was connected through the corpath grx cassette. The radiation source from the beta-cath system was sent out and was not seen in the fluoro. The physician then attempted to retract the radiation source and it would not retract. The physician then manually removed the beta-cath catheter. Once the cover of the corpath grx cassette was opened, the radiation source returned to the beta-cath system. The beta-cath catheter was replaced and the procedure was completed manually. It was estimated by the site staff that the incident caused the physician to receive approximately 4. 5 msv of radiation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007822508-2017-00001 |
| MDR Report Key | 6959675 |
| Report Source | OTHER |
| Date Received | 2017-10-18 |
| Date of Report | 2017-10-17 |
| Date of Event | 2017-10-03 |
| Date Mfgr Received | 2017-10-03 |
| Date Added to Maude | 2017-10-18 |
| 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 | STEERABLE CATHETER CONTROL SYSTEM |
| Product Code | DXX |
| Date Received | 2017-10-18 |
| Model Number | 304 |
| Catalog Number | 304 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Other | 2017-10-18 |