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 09/17/2019

Event Type  malfunction  

Event Description

It was reported that the distal filter was unable to be recaptured.A patient presented for a transcatheter aortic valve replacement (tavr) procedure.The patients anatomy was very tortuous with severe calcification which made device tracking problematic.As the sentinel device was attempted to be recaptured to reposition, the distal filter slider was pulled out and detached from the handle.This occurred while the distal filter was deployed.A decision was made to retrieve the whole system with the distal filter still deployed.The sentinel device was removed without any patient issues.

Event Description

It was reported that the distal filter was unable to be recaptured.A patient presented for a transcatheter aortic valve replacement (tavr) procedure.The patients anatomy was very tortuous with severe calcification which made device tracking problematic.As the sentinel device was attempted to be recaptured to reposition, the distal filter slider was pulled out and detached from the handle.This occurred while the distal filter was deployed.A decision was made to retrieve the whole system with the distal filter still deployed.The sentinel device was removed without any patient issues.

Manufacturer Narrative

H3 - device eval by manufacturer: analysis of the returned product revealed the skeleton returned broken and the distal filter slider (#3) was detached.The inner member was exposed through the tip of the device due to the detachment.The articulating sheath shows signs of pinching.During functional testing, no flushing was able to be performed and none of the filters would advance or retract.The inner member was cut through the skeleton break location to free the distal filter and articulating sheath.A guidewire was inserted, in order to manually move the filter in and out of the sheath, and distal filter was able to be retracted and deployed (a considerable amount of blood had to be cleaned off).Hypotube was also removed from the device in order to visualize the detachment location of the inner member inside the rear handle.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): CLARET MEDICAL, INC.; 1745 copperhill parkway; suite 1; santa rosa CA 95403
• MDR Report Key: 9196910
• MDR Text Key: 163154933
• Report Number: 2134265-2019-12192
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• PMA/PMN Number: DEN160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2021
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 19H01H19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 11/11/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR