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

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 device was returned with returned with the following conditions: the distal filter slider (#3) was detached and not returned.A portion of inner member was protruding from the proximal end of the device.Additionally, the inner member was found kinked.The proximal filter was sheathed.The articulating distal sheath (ads) slightly was flexed.The distal filter was un-sheathed.Flushing was achieved as expected through the rear handle flush port and front handle flush port.Flushing could not be performed through the distal filter slider (#3) due to detachment.Microscopic inspection revealed a clean detachment of the inner member from the hypotube was confirmed.Functional testing was performed.A test guidewire was fully inserted.The proximal filter sheathed and un-sheathed using proximal filter slider (#1).The articulating distal sheath (ads) responded as expected when turning articulating knob (#2).The distal filter could not be sheathed and un-sheathed using distal filter slider (#3) due to the detachment of it.

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 distal filter was returned unsheathed with a broken distal filter slider.

• 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: 11516669
• MDR Text Key: 240690763
• Report Number: 2134265-2021-02828
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2021

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 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
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1