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

Model Number CMS15-10C-US

Device Problems Mechanical Problem (1384); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: analysis of returned product revealed that the 6f non-boston scientific (bsc) introducer sheath could not be removed from the sentinel device due to the severely damaged condition of the 6f non-bsc introducer sheath (buckling/accordioned and detached from its hub) and due to the severely damaged condition of the articulating distal sheath (ads) (severely kinked with pinch marks along its length) of the sentinel embolic protection system.The ads responded when turning articulating knob (#2); however, could not reached it full straight position due to its severe damaged condition; consequently, confirming the reported complaint.Additionally, the distal filter slider (#3) is bent/kinked and the distal filter was able to be un-sheathed using distal filter slider (#3) by removing the kink on it and it was found severely damaged, the tri-layer is missing and the distal filter is detached from the distal tip.The coupler was found stretched.

Event Description

Reportable based on returned device analysis completed (b)(6) 2021.It was reported that difficulty removing through the introducer sheath occurred.Vascular access was obtained via a transradial approach.A 6f non-boston scientific (bsc) introducer sheath was placed.A sentinel embolic protection system was positioned and both filters deployed.The transcatheter aortic valve replacement (tavr) procedure was successfully completed.The distal and proximal filters of the sentinel embolic protection system were sheathed.When the sentinel embolic protection system was exiting the 6f non-bsc introducer sheath, the physician felt resistance.The sentinel embolic protection system and the 6f introducer sheath were removed together.Outside the patient, a kink and damage was found on the 6f non-bsc introducer sheath.No patient complications were reported.Returned device analysis found a detached distal filter.

• 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: 11726637
• MDR Text Key: 247515938
• Report Number: 2134265-2021-05262
• 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: Physician
• Type of Report: Initial
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2022
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0026153812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2020
• 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
• Patient Age: 88 YR