MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 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 10/06/2020

Event Type  malfunction  

Event Description

It was reported that an inability to resheath the distal filter occurred.The patient with a type one aortic arch was selected for a transcatheter aortic valve implantation (tavi) procedure.A sentinel cerebral protection system was used.At the end of the procedure, the physician attempted to resheath the distal filter of the sentinel cerebral protection system.The distal filter slider on the sentinel handle broke while the distal filter was still deployed state.The physician was able to resheath the distal filter manually by using a clamp to pull on the hypotube.The proximal filter was then re-sheathed and the sentinel cerebral protection system was removed without further incident.There were no patient consequences.

Manufacturer Narrative

The sentinel cerebral protection system was returned for analysis with an unknown guidewire and an unknown introducer sheath.The distal end of the sentinel cerebral protection system was inside the introducer sheath and the guidewire was inserted into the device.Upon visual inspection, a portion of the inner member was found to be protruding from the proximal end of the sentinel cerebral protection system.The inner member was without visible damages under the rear handle shells.The distal filter slider was detached, the distal filter and the proximal filter were sheathed, and the articulating distal sheath was relaxed.Microscopic inspection revealed a clean detachment of the inner membrane from the hypotube.Functional tests concluded the distal filter could not be sheath or unsheathed due to the distal filter slider detachment.

Event Description

It was reported that a handle break and inability to resheath the distal filter occurred.The patient with a type one aortic arch was selected for a transcatheter aortic valve implantation (tavi) procedure.A sentinel cerebral protection system was used.At the end of the procedure, the physician attempted to resheath the distal filter of the sentinel cerebral protection system.The distal filter slider on the sentinel handle broke while the distal filter was still deployed state.The physician was able to resheath the distal filter manually by using a clamp to pull on the hypotube.The proximal filter was then re-sheathed and the sentinel cerebral protection system was removed without further incident.There were no patient consequences.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM (US)
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10727149
• MDR Text Key: 212758378
• Report Number: 2134265-2020-14405
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2022
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0025786901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Date Manufacturer Received: 11/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1