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

Model Number CMS15-10C-US

Device Problems Positioning Failure (1158); Positioning Problem (3009)

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

Event Date 08/09/2021

Event Type  malfunction  

Event Description

(b)(6) study.It was reported that the distal filter was dislodged in an open state.Procedure summary: prior to the index procedure, heparin or another anticoagulant was given.The subject was on a prior regimen of aspirin at the time of index procedure.The subject did not receive a loading dose of aspirin.After heparin has been given and prior to sentinel cerebral protection system (cps) insertion, the activated clotting time (act) was 446 sec.An unknown manufacturer's introducer sheath was placed into the right radial artery and a sentinel cps was inserted with the proximal filter into the brachiocephalic artery and distal filter into the left common carotid artery.A 26 mm non-boston scientific (bsc) valve and delivery system were advanced to the native aortic annulus.At that point of time, the subject moved their arm and neck as the non-bsc valve advanced to aortic arch, and the distal filter of the sentinel cps pulled down from carotid artery to the aorta while in an open state.The distal filter of the sentinel cps became hooked around the non-bsc valve delivery system and when an attempt was made to redeploy the distal filter of the sentinel cps , the distal filter was unable to be redeployed in the carotid without pulling out the non-bsc valve delivery sheath.The procedure was completed with only the proximal filter of the sentinel cps deployed.Post dilatation was performed.Both the distal filter and proximal filter of the sentinel cps were fully resheathed prior to removal without any complications.One day post index procedure, the subject was discharged on aspirin and clopidogrel.

• 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; 3636 n. laughlin blvd, suite 1; santa rosa CA 95403
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13362032
• MDR Text Key: 284525102
• Report Number: 2134265-2021-16759
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2022

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: 02/05/2023
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0026762025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2022
• Initial Date FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Race: White