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

Model Number CMS15-10C-US

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2020

Event Type  malfunction  

Event Description

Same case as facility medwatch reference (b)(4).It was reported that distal filter failed to retrieve and the guidewire was stuck.A sentinel cerebral protection system was used during a transcatheter aortic valve implantation (tavi) procedure.The sentinel device was inserted through the right radial artery access site into a 6fr non-boston scientific sheath.At the end of the procedure there was difficulty removing the sentinel device.The guidewire stuck and the distal filter was removed in the deployed state.Upon removal of the sentinel device it was noticed that the introducer sheath was broken and a piece was sheared off and attached to the sentinel device at the level of the undeployed filter.No intervention was required and no harm to the patient was noted.

Event Description

Same case as facility medwatch reference 1000440000-2020-8004 it was reported that distal filter failed to retrieve and the guidewire was stuck.A sentinel cerebral protection system was used during a transcatheter aortic valve implantation (tavi) procedure.The sentinel device was inserted through the right radial artery access site into a 6fr non-boston scientific sheath.At the end of the procedure there was difficulty removing the sentinel device.The guidewire stuck and the distal filter was removed in the deployed state.Upon removal of the sentinel device it was noticed that the introducer sheath was broken and a piece was sheared off and attached to the sentinel device at the level of the undeployed filter.No intervention was required and no harm to the patient was noted.

Manufacturer Narrative

H6 patient codes - updated to imdrf coding h6 impact codes - updated h3 device evaluated by mfr: the device was returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The unit was returned with a section of an introducer sheath loaded and a guidewire loaded.The proximal filter was sheathed within the introducer sheath.The articulating distal sheath (ads) was slightly flexed and severely kinked.The distal filter slider (#3) was detached and not returned.The distal filter was un-sheathed.The distal tip of the guidewire protruding from the distal tip of the sentinel device.The guidewire could not be removed from the device, it is stuck.The proximal filter was sheathed and un-sheathed using proximal filter slider (#1).The ads responded as expected when turning articulating knob (#2) even with the kinks on it.The distal filter could not be un-sheathed due to distal filter slider (#3) detachment.X-ray confirmed the ads pull wire was severely damaged and the guidewire stuck at the distal end of the sentinel device.The distal tip of the guidewire was protruding from the distal tip of the sentinel device.Microscopic inspection revealed clean detachment of the inner member from the hypotube.

• 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
• MDR Report Key: 10901059
• MDR Text Key: 219491349
• Report Number: 2134265-2020-16124
• Device Sequence Number: 1
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: 00863229000004
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2022
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0025997745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Date Manufacturer Received: 01/25/2021
• Patient Sequence Number: 1
• Patient Age: 91 YR
• Patient Weight: 69