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

Model Number CMS15-10C-US

Device Problems Difficult or Delayed Positioning (1157); Positioning Failure (1158); Defective Device (2588); Difficult to Advance (2920); Difficult to Open or Close (2921); Positioning Problem (3009); Physical Resistance/Sticking (4012)

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

Event Date 01/04/2024

Event Type  malfunction  

Event Description

It was reported the proximal filter moved out of position in an open state.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve replacement (tavr) procedure.An attempt was made to load the sentinel cps onto a guidewire that was already placed in the patient anatomy.The guidewire became kinked and difficulty was encountered when the operators attempted to remove the guidewire through the sentinel cps.A non-boston scientific (bsc) angioplasty balloon catheter was advanced through the sentinel cps in an effort to aid retrieval of the kinked guidewire.The distal filter of the sentinel cps became partially deployed when the non-bsc angioplasty balloon catheter was inserted and the distal filter slider became kinked.The sentinel cps was removed from the patient with the distal filter protruding slightly from the sheath, flushed with heparinzed saline, and the distal filter slider was manually straightened.The sentinel cps was reintroduced into the patient anatomy and difficulty advancing through the brachial artery was encountered.The sentinel cps was positioned and the proximal filter successfully deployed.An attempt was made to cannulate the left common carotid artery with the articulating sheath in the descending aorta.The sentinel cps was manually manipulated in an attempt to reposition the device and the proximal filter moved to the right subclavian artery.The proximal filter was recaptured, repositioned, and failed to deploy due to the inability to move the proximal filter slider.The sentinel cps was again removed from the patient, flushed with heparinzed saline, the proximal filter slider became operable, and the proximal filter was able to be partially deployed.A second sentinel cps was used to proceed with the procedure.During removal of the second sentinel cps difficulties were experienced moving the proximal filter slider but ultimately the proximal filter was resheathed and the device safely removed from the patient.No patient complications were reported.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM (US)
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18539831
• MDR Text Key: 333324162
• Report Number: 2124215-2024-00700
• Device Sequence Number: 1
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: 00863229000004
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K192460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• 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
• Device Lot Number: 0029559179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female