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

Model Number CMS15-10C-US

Device Problems Break (1069); Mechanical Problem (1384); Difficult to Remove (1528); Device-Device Incompatibility (2919)

Patient Problem Perforation of Vessels (2135)

Event Date 08/06/2020

Event Type  Injury  

Event Description

It was reported that removal difficulty and a hematoma at the access site occurred.A sentinel cerebral protection system was used during a transcatheter aortic valve replacement (tavr) procedure.The patient anatomy was normal.Vascular access for the sentinel cerebral protection system was obtained via a radial approach.The physician attempted to straighten the catheter by rotating the articulation knob on the device handle; however, the handle became disassembled.In an attempt to troubleshoot, the physician pulled the sentinel device back hoping the articulating sheath would relax and the catheter would straighten.Pulling the sentinel back caused the non-bsc radial sheath to accordion.The physician was able to remove the sentinel device by pulling hard with both filters captured.The articulating sheath on the sentinel device was removed from the patient in a curled state.The result was a hematoma at the radial access site.The hematoma was managed with compression.The patient is fine.

Event Description

It was reported that removal difficulty and a hematoma at the access site occurred.A sentinel cerebral protection system was used during a transcatheter aortic valve replacement (tavr) procedure.The patient anatomy was normal.Vascular access for the sentinel cerebral protection system was obtained via a radial approach.The physician attempted to straighten the catheter by rotating the articulation knob on the device handle; however, the handle became disassembled.In an attempt to troubleshoot, the physician pulled the sentinel device back hoping the articulating sheath would relax and the catheter would straighten.Pulling the sentinel back caused the non-bsc radial sheath to accordion.The physician was able to remove the sentinel device by pulling hard with both filters captured.The articulating sheath on the sentinel device was removed from the patient in a curled state.The result was a hematoma at the radial access site.The hematoma was managed with compression.The patient is fine.

Manufacturer Narrative

D4: lot number: updated d4: expiration date: updated d4:unique identifier (udi) #: updated d10 device available for evaluation,returned to manufacture date - updated h4: device manufacture date: updated h3: device eval by manufacturer: the sentinel device was returned to boston scientific and analyzed by a bsc quality engineer.Th unit returned has the distal filter slider #3 bent, as part of overall visual revision.Visual inspection revealed that the unit was returned with a unknown guidewire (inserted in the device) and a severely damaged unknown introducer sheath with the distal end of the device introduced in it.The distal filter slider (#3) was kinked.The inner member without visible damages is noted under the rear handle shells.A visible portion of the y-hub is noted between articulating knob (#2) and rear handle shells.The proximal filter was un-sheathed.The distal filter was returned sheathed.It was returned within the unknown introducer sheath.The articulating sheath (ads) was relaxed with a kink (within the unknown introducer sheath).Flow testing indicated flushing was unable to be performed through distal filter slider (#3) due to guidewire inserted.Flushing was achieved as expected through front and rear handle flush ports.Functional testing revealed the ads did not responded as expected when turning articulating knob (#2) due to the severely damaged condition of the unknown introducer sheath.The proximal filter could not be sheathed/un-sheathed using proximal filter slider (#1) due to the severely damaged condition of the unknown introducer sheath.The distal filter could not be un-sheathed using the distal filter slider (#3) due to the kink on it.A section of the unknown introducer sheath was able to be longitudinally cut and removed.The proximal filter was able able to be sheathed/un-sheathed using the proximal filter slider (#1) after dissection of the introducer sheath.The ads responded as expected when turning articulating knob (#2) after dissection of the introducer sheath even with the kink in it.The kink of the distal filter slider (#3) was removed and the distal filter was able to be sheathed and un-sheathed.Microscopic inspection revealed drag marks under the articulating knob.

• 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: 10430870
• MDR Text Key: 203834865
• Report Number: 2134265-2020-11333
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2022
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0025337598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Date Manufacturer Received: 09/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention