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); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2019

Event Type  malfunction  

Event Description

It was reported that the distal filter could not be recaptured.Procedure summary: a sentinel embolic protection device was being used in a transcatheter aortic valve replacement (tavr) procedure.It was difficult to place the distal portion of the sentinel in the left common carotid artery (lcca) due to the severe kinking of the aortic arch.The sentinel was eventually deployed successfully.The tavr procedure was finished without issues.When the physician tried to remove the sentinel catheter it was not possible to retract the distal filter slider (#3) to recapture the distal filter.After several attempts, the distal filter slider broke.The sentinel was withdrawn with the distal filter still in the deployed state.There was no patient harm.

Manufacturer Narrative

Analysis of returned product revealed the distal filter hypotube was hanging from the guidewire (still inside the device) and the innermember was detached due to buckling; distal filter was returned in an extended position.Functional inspection could not be performed due to the state of the returned device.Device condition is consistent with the reported allegation, consequently, confirming the reported complaint.

Event Description

It was reported that the distal filter could not be recaptured.Procedure summary: a sentinel embolic protection device was being used in a transcatheter aortic valve replacement (tavr) procedure.It was difficult to place the distal portion of the sentinel in the left common carotid artery (lcca) due to the severe kinking of the aortic arch.The sentinel was eventually deployed successfully.The tavr procedure was finished without issues.When the physician tried to remove the sentinel catheter it was not possible to retract the distal filter slider (#3) to recapture the distal filter.After several attempts, the distal filter slider broke.The sentinel was withdrawn with the distal filter still in the deployed state.There was no patient harm.

• 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: 8856683
• MDR Text Key: 153150379
• Report Number: 2134265-2019-09025
• 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: 09/12/2019

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: 06/30/2021
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 19F05H13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 08/02/2019
• Supplement Dates Manufacturer Received: 08/19/2019
• Supplement Dates FDA Received: 09/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR