MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENTINEL CEREBRAL PROTECTION SYSTEM (US); EMBOLIC PROTECTION DEVICE

Model Number CMS15-10C-US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: 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.Visual inspection of the returned device found the device was returned with the following conditions: the unit was returned with an unknown introducer sheath.The introducer sheath was found severely damaged.It was buckled/accordioned in its distal end.Additionally, residues of blood were observed in it.The outer sheath of the sentinel device was kinked.The distal filter slider (#3) was bent/kinked.The proximal filter was un-sheathed.The articulating distal sheath (ads) was flexed; however, it was found severely damaged.It was buckled/accordioned and detached from its proximal bond.The distal filter was sheathed.Flushing was achieved as expected through distal filter slider (#3), the rear handle flush port and the front handle flush port.Microscopic inspection revealed a severely damaged condition of the articulating distal sheath (ads) was confirmed.Functional testing was performed with a test guidewire was fully inserted.The proximal filter was sheathed and un-sheathed using proximal filter slider (#1).The articulating distal sheath (ads) did not responded as expected when turning articulating knob (#2), there is no response due to the severely damaged condition of the articulating distal sheath (ads).The distal filter could not be un-sheathed using distal filter slider (#3) due to the severely damaged condition of the articulating distal sheath (ads).The articulating distal sheath (ads) was longitudinally cut in order to expose the distal filter to inspection.No damages were observed in the distal filter.

Event Description

A sentinel device embolic protection device was returned to boston scientific from an unknown customer with no reported information.Returned device analysis found the proximal filter was returned unsheathed within an unspecified 6f introducer sheath.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC; 1745 copperhill parkway; suite 1; santa rosa CA 95403
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11566095
• MDR Text Key: 242690772
• Report Number: 2134265-2021-02888
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• PMA/PMN Number: K192460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Date Manufacturer Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1