MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-19 for SENTINEL CEREBRAL PROTECTION SYSTEM CMS15-10C-US manufactured by Claret Medical, Inc..
[142532925]
The event date has been estimated to be (b)(6) 2019 based on the aware date of (b)(6) 2019, as the exact event date is unknown
Patient Sequence No: 1, Text Type: N, H10
[142532926]
It was reported a stroke occurred. The patients medical history was significant for stroke. Heparin was given to the patient before the procedure. Several times during the procedure, the patients blood pressure dropped into the 40s. The patient was given chest compressions to bring up the blood pressure. There were no issues with deploying or removing the sentinel device. The physician thought that the procedure was done and removed the sentinel device. The physician then proceeded to perform a post-dilatation on the implanted valve without the sentinel device deployed. 72 hours after the procedure, the patient had an ischemic stroke, located on the right side. The patient experienced temporary paralysis. Thrombolytics were given to treat the stroke and the patient regained movement after two hours. The patient is now fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2019-04015 |
| MDR Report Key | 8532831 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-19 |
| Date of Report | 2019-04-19 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-03-28 |
| Date Added to Maude | 2019-04-19 |
| 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 | SONALI ARANGIL |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 6515827403 |
| Manufacturer G1 | CLARET MEDICAL, INC. |
| Manufacturer Street | 1745 COPPERHILL PARKWAY SUITE 1 |
| Manufacturer City | SANTA ROSA CA 95403 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95403 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENTINEL CEREBRAL PROTECTION SYSTEM |
| Generic Name | EMBOLIC PROTECTION DEVICE |
| Product Code | PUM |
| Date Received | 2019-04-19 |
| Model Number | CMS15-10C-US |
| Catalog Number | CMS15-10C-US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLARET MEDICAL, INC. |
| Manufacturer Address | 1745 COPPERHILL PARKWAY SUITE 1 SANTA ROSA CA 95403 US 95403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-19 |