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

Model Number CMS15-10C-US

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

Year of birth: (b)(6).

Event Description

It was reported that the distal filter was unable to be retrieved.Qualifying conditions: type one arch with a bifurcate right coronary artery.There is moderate tortuosity, mostly free from calcium, with some eccentric, ostial calcification of the innominate artery.Vascular access was obtained via the right radial artery.A transcatheter aortic valve replacement procedure was performed with the use of a sentinel cerebral protection system.During removal of the sentinel cerebral protection system, the #3 slider broke and the distal filter was unable to pull the distal filter into the system.The metal part slipped off the inner member.The physician pushed the handle together to disengage the left common carotid and the sentinel cerebral protection system was removed from the patient.No issues with the patient were reported.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM (US)
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): CLARET MEDICAL, INC.; 1745 copperhill parkway; santa rosa CA 95403
• Manufacturer (Section G): CLARET MANUFACTURING; 1745 copperhill parkway; suite 1; santa rosa CA 95403
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9491117
• MDR Text Key: 176635983
• Report Number: 2134265-2019-15697
• Device Sequence Number: 1
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: 00863229000004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 19H01H20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2019
• 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
• Patient Age: 77 YR
• Patient Weight: 94