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 04/26/2022

Event Type  malfunction  

Manufacturer Narrative

Device analysis: visual inspection of the returned device found the proximal filter sheathed, the distal filter sheathed, the articulating sheath ads relaxed, the hypotube kinked and the outer shaft kinked.X-ray inspection found the pull wire was damaged.Functional testing found before flushing, articulating sheath ads was unable to be flexed using knob #2 and the proximal filer was unable to be deployed.After flushing the proximal filter was unable to be deployed.Dissection and microscopic testing found the pull wire was detached/separated.A transversal cut was performed on the distal part of the outer shaft/sheath and no damage was found on the inner shaft.The proximal filter was found torn.

Event Description

Reportable based on returned device analysis completed (b)(6) 2022.It was reported that the proximal filter failed to deploy.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.Following deployment of the proximal filter, lcc could not be achieved.The proximal filter was recaptured and repositioned, but it was unable to be released again.The sentinel cps was successfully retrieved and replaced with another sentinel cps to complete the procedure.No patient complications were reported.However returned device analysis found the proximal filter was found torn.

• 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: 15524415
• MDR Text Key: 302353515
• Report Number: 2134265-2022-08813
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 09/30/2022

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 Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1