SENTINEL CEREBRAL PROTECTION SYSTEM CMS15-10C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-10-16 for SENTINEL CEREBRAL PROTECTION SYSTEM CMS15-10C manufactured by Claret Medical, Inc..

MAUDE Entry Details

• Report Number: 2134265-2019-12192
• MDR Report Key: 9196910
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-10-16
• Date of Report: 2019-10-16
• Date of Event: 2019-09-17
• Date Mfgr Received: 2019-09-17
• Device Manufacturer Date: 2019-07-30
• Date Added to Maude: 2019-10-16
• 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: 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 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

Device Details

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM
• Generic Name: EMBOLIC PROTECTION DEVICE
• Product Code: PUM
• Date Received: 2019-10-16
• Returned To Mfg: 2019-10-04
• Model Number: CMS15-10C
• Catalog Number: CMS15-10C
• Lot Number: 19H01H19
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: N
• 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

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-10-16