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); Difficult to Remove (1528); Defective Device (2588); Positioning Problem (3009)

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

Event Date 08/01/2022

Event Type  malfunction  

Event Description

It was reported that proximal filter dislodgement and an inability to fully resheath the proximal filter occurred.A sentinel cerebral protection system (cps) was selected for use during a transcatheter aortic valve implantation (tavi) procedure.The vasculature was nontortuous.An introducer sheath was placed into the radial artery and the sentinel cps was advanced.The proximal filter of the sentinel cps was deployed in brachiocephalic artery.While articulating the distal end of the sentinel cps, the proximal filter moved from the brachiocephalic artery towards the subclavian artery in an open state.The physician attempted to recapture the proximal filter of the sentinel cps: however, the proximal filter of the sentinel cps could not be fully resheathed.The physician repositioned the proximal filter more proximally in the brachiocephalic artery and attempted to redeploy the proximal filter, however, the proximal filter slider exhibited resistance and the proximal filter would not fully open.The sentinel cps was potentially retrieved from the patient in a partially open state.No patient complications were reported.

Event Description

It was reported that proximal filter dislodgement and an inability to fully resheath the proximal filter occurred.A sentinel cerebral protection system (cps) was selected for use during a transcatheter aortic valve implantation (tavi) procedure.An introducer sheath was placed into the radial artery and the sentinel cps was advanced.The proximal filter of the sentinel cps was deployed in brachiocephalic artery.While articulating the distal end of the sentinel cps, the proximal filter moved from the brachiocephalic artery towards the subclavian artery in an open state.The physician attempted to recapture the proximal filter of the sentinel cps: however, the proximal filter of the sentinel cps could not be fully resheathed.The physician repositioned the proximal filter more proximally in the brachiocephalic artery and attempted to redeploy the proximal filter, however, the proximal filter slider exhibited resistance and the proximal filter would not fully open.The sentinel cps was potentially retrieved from the patient in a partially open state.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the sentinel cps was returned to boston scientific (bsc) and was analyzed by a bsc quality engineer.Visual analysis revealed a sheathed proximal filter, relaxed articulating distal sheath (ads), unsheathed distal filter, and excessive blood residues along the sentinel cps.A functional test was performed and found that before flushing the sentinel cps, the proximal filter was unable to be unsheathed via the proximal filter slider.Following flushing of the sentinel cps, the proximal filter could be successfully unsheathed via the proximal filter slider.The sentinel cps was left soaking for 24 hours, and when the flushing was performed, excessive blood exited the sentinel cps.After soaking the sentinel cps, the proximal filter was unable to be unsheathed.A microscope test was performed, which found the outer shaft to be stretched.A dissection test was performed using scissors to create a transversal cut on the distal part of the outer shaft.A protruding braid was found on the inner shaft of the sentinel cps.The type of damages observed on the outer shaft in the device indicates that an excessive force may have been applied during the attempt to deploy the proximal filter that may have caused the stretch on the outer shaft.

• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15192596
• MDR Text Key: 304906733
• Report Number: 2134265-2022-08374
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2023
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0028152233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female