MAUDE Adverse Event Report: CLARET MEDICAL, INC. SENTINEL; TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES

Model Number CMS15-10C-US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 12/17/2019

Event Type  malfunction  

Event Description

Postoperative stroke - new supply used during procedure - sentinel cerebral protection system - lot # 19g08h21, exp.07/31/2021; device not kept not noted to be defective.Sentinel device used to prevent embolic stroke.Uncertain as to why stroke occurred.Signs of stroke not evident until patient in pacu therefore device was not retained post procedure.

• Brand Name: SENTINEL
• Type of Device: TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES
• Manufacturer (Section D): CLARET MEDICAL, INC.; 1745 copperhill pkwy; suite 1; santa rosa CA 95403
• MDR Report Key: 10038385
• MDR Text Key: 190337020
• Report Number: 10038385
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 19G08H21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30295 DA