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

Model Number CMS15-10C-US

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the sentinel embolic protection system 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 returned device matches with the product family provided by the customer.Visual inspection of the returned device revealed the unit was returned with a unknown guidewire.The proximal filter was sheathed.The articulating distal sheath (ads) was relaxed.The distal filter was partially un-sheathed.Functional testing indicated the returned guidewire was unable to be advanced/retracted from the sentinel embolic protection device, it is stuck.The distal filter could not be un-sheathed using distal filter slider (#3).The sentinel embolic protection system was dissected.The ads had to be longitudinally cut in order to expose the distal filter for inspection.No issues were detected in the distal filter.The distal filter assembly was detached from the inner member in order to locate where the guidewire is stuck.The distal filter assembly was easily advanced from the guidewire.The distal filter slider (#3) was pulled out and the inner member was found buckled/accordion.In this location the guidewire was stuck.Microscopic inspection revealed the inner member was found buckled/accordion confirmed.

Event Description

Reportable on device analysis completed 10 march 21.The physician attempted to advance a sentinel embolic protection system over a 014 non-boston scientific guide wire.The physician was not able to fully advance the sentinel embolic protection system over the 014 non-bsc guide wire.It was unknown how much of the sentinel embolic protection system was able to be advanced over the 014 non-bsc guide wire before the issue occurred.The procedure was completed with a new sentinel embolic protection system and a new 014 non-bsc guide wire.No patient complications were reported.However, returned device analysis revealed the distal filter was returned in an open state.

• 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 CORPORATION; 160 knowles drive; los gatos CA 95032
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11569097
• MDR Text Key: 242723798
• Report Number: 2134265-2021-03190
• Device Sequence Number: 1
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: 00863229000004
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2021

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 Expiration Date: 10/20/2022
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0026219704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2021
• Initial Date FDA Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2020
• 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