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

Model Number CMS15-10C

Device Problem Positioning Problem (3009)

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

Event Date 07/04/2023

Event Type  malfunction  

Event Description

It was reported that 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.The sentinel cps was advanced into position via radial access and the proximal filter was successfully deployed.Several attempts were made to steer the sentinel cps into the left common carotid artery.During one attempt the proximal filter moved out of position in an open state.The proximal filter was recaptured and the sentinel cps was removed from the patient.The tavr procedure was completed without the use of a second sentinel cps device.No patient complications were reported.

Manufacturer Narrative

H3 device evaluated by mfr: the returned device consisted of a sentinel cerebral protection system (cps).Visual inspection revealed the distal filter and proximal filters were both sheathed, the articulating distal sheath was relaxed, the distal filter slider was kinked, and the proximal sheath was kinked and stretched.During functional testing the proximal filter was unable to be deployed due to the kink in the sheath of the proximal filter slider.The articulating distal sheath was unable to be rotated due to the proximal sheath kinks.

Event Description

It was reported that 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.The sentinel cps was advanced into position via radial access and the proximal filter was successfully deployed.Several attempts were made to steer the sentinel cps into the left common carotid artery.During one attempt the proximal filter moved out of position in an open state.The proximal filter was recaptured and the sentinel cps was removed from the patient.The tavr procedure was completed without the use of a second sentinel cps device.No patient complications were reported.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM
• 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: 17374087
• MDR Text Key: 319531276
• Report Number: 2124215-2023-37131
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2024
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 0029260856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Race: Asian