MAUDE Adverse Event Report: CLARET MEDICAL, INC. SENTINEL CEREBRAL PROTECTION SYSTEM; EMBOLIC PROTECTION DEVICE

Model Number CMS15-10C

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that the distal filter was unable to be resheathed.Vascular access was obtained via right radial approach.A sentinel embolic protection device was positioned.At the end of the procedure, when attempting to resheath the distal filter, the distal filter slider broke.The physician was unable to resheath the distal filter.The sentinel embolic protection device was removed together with the radial sheath from the patient with the distal filter of the sentinel embolic protection device in a fully deployed state.No patient complications were reported.Following the procedure, the patient's status was stable.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): CLARET MEDICAL, INC.; 1745 copperhill parkway; santa rosa CA 95403
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 160 knowles drive; los gatos CA 95032
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10320424
• MDR Text Key: 200256932
• Report Number: 2134265-2020-09824
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: DEN160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2022
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 0025337597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1