MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-18 for SENTINEL CEREBRAL PROTECTION SYSTEM (US) CMS15-10C-US manufactured by Claret Medical, Inc..
[184051666]
Device evaluated by mfr: unit returned with its original pouch batch 19f07h21, overall visual revision did not identify failures or evidence that could be lost due to decontamination process. Although there is no information regarding the event/issue occurred, the blood found during analysis signals to device being used inside a patient. Product analysis showed the device had blood traces, the ads was slightly flexed, distal filter was un-sheathed and showed no damages, and the proximal filter was returned sheathed. Proximal sheath came back with a kink in the transition tube. Microscopic inspection found pinching and slight twist marks at the distal end of the proximal sheath, there were also wear signs as well as a hole in the proximal end of the sheath; and inner member buckling was found under the rear handles. When flushing was attempted through front handle flush port, fluid would come out from a hole in the proximal sheath. Functional test confirmed a test guidewire could be advanced approx. 1345 mm into the device (not fully), the distal filter sheathed/un-sheathed using the distal filter slider, however more force than usual was required to do so. And the proximal filter would not sheath/un-sheath. Kink in transition tube was corrected (rounded) and slider #1 was moved however, the proximal sheath "gave" separating at the exact location of the wear marks and hole found during microscopic inspection. Device was submitted for x-ray inspection in which the proximal filter frame and shoulders were visibly damaged inside the sheath; location matched the twisting/pinching found. Additionally, part of the proximal sheath was cut in order to release the proximal filter. Both the filter and its frame were damaged, frame was bent/kinked (as seen during x-ray) and the filter was torn. Skeleton was also found separated from the core wire, apparently from tension caused while attempting proximal filter deployment.
Patient Sequence No: 1, Text Type: N, H10
[184051667]
Reportable based on returned device analysis completed 06 march 2020 which revealed a torn filter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2020-02943 |
| MDR Report Key | 9850207 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-06-04 |
| Date Added to Maude | 2020-03-18 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAY JOHNSON |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634942574 |
| Manufacturer G1 | CLARET MANUFACTURING |
| 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 (US) |
| Generic Name | EMBOLIC PROTECTION DEVICE |
| Product Code | PUM |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-01-31 |
| Model Number | CMS15-10C-US |
| Catalog Number | CMS15-10C-US |
| Lot Number | 19F07H21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLARET MEDICAL, INC. |
| Manufacturer Address | 1745 COPPERHILL PARKWAY SANTA ROSA CA 95403 US 95403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |