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

Model Number CMS15-10C

Device Problems Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

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

Event Date 07/14/2022

Event Type  malfunction  

Event Description

It was reported that a proximal filter dislodgement occurred.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve implantation (tavi) procedure.An introducer sheath was placed into the radial artery and the sentinel cps was advanced and positioned with the proximal filter into brachiocephalic artery.The proximal filter was successfully deployed into the brachiocephalic artery.Upon cannulating to the left common carotid artery with the articulating distal sheath, the proximal filter dislodged from the brachiocephalic artery in an open state.The proximal filter was recaptured and repositioned in the brachiocephalic artery under fluoroscopy.However, the proximal filter slider exhibited resistance and the proximal filter would not open.The sentinel cps was successfully retrieved and replaced with another sentinel cps to complete the procedure.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, unsheathed distal filter, and outer shaft kink near the handle.X ray inspection revealed no damage in the braids of the inner shaft.A functional test was performed and found that before flushing the sentinel cps, the proximal filter was unable to be unsheathed using the proximal filter slider (#1).After flushing the sentinel cps, the proximal filter was still unable to be unsheathed using the proximal filter slider (#1).A dissection test was performed using scissors to create a transversal cut on the distal part of the outer shaft.After the dissection, no damage was observed in the braids of the inner shaft.

Event Description

It was reported that a proximal filter dislodgement occurred.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve implantation (tavi) procedure.An introducer sheath was placed into the radial artery and the sentinel cps was advanced and positioned with the proximal filter into brachiocephalic artery.The proximal filter was successfully deployed into the brachiocephalic artery.Upon cannulating to the left common carotid artery with the articulating distal sheath, the proximal filter dislodged from the brachiocephalic artery in an open state.The proximal filter was recaptured and repositioned in the brachiocephalic artery under fluoroscopy.However, the proximal filter slider exhibited resistance and the proximal filter would not open.The sentinel cps was successfully retrieved and replaced with another sentinel cps to complete the procedure.No patient complications were reported.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM
• 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: 15159988
• MDR Text Key: 304961097
• Report Number: 2134265-2022-08134
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K192460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

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: 10/20/2023
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 0028237086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Race: Asian