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

Model Number CMS15-10C

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 08/29/2023

Event Type  malfunction  

Event Description

It was reported that the proximal filter and the distal filter both failed to be recaptured.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve replacement (tavr) procedure.The sentinel cps was advanced into position and the proximal and distal filters were successfully deployed.Upon completion of the tavr procedure, the proximal and distal filter could not be recaptured into the catheter.The distal filter slider became detached and the proximal filter slider could only be moved a few centimeters.The sentinel cps and introducer sheath were removed from the patient as a unit with both the proximal and distal filters in an open state.There were no patient consequences reported.

Event Description

It was reported that the proximal filter and the distal filter both failed to be recaptured.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve replacement (tavr) procedure.The sentinel cps was advanced into position and the proximal and distal filters were successfully deployed.Upon completion of the tavr procedure, the proximal and distal filter could not be recaptured into the catheter.The distal filter slider became detached and the proximal filter slider could only be moved a few centimeters.The sentinel cps and introducer sheath were removed from the patient as a unit with both the proximal and distal filters in an open state.There were no patient consequences reported.

Manufacturer Narrative

H3 device evaluated by mfr: the sentinel cps was returned and analyzed by a bsc quality technician.The sentinel cps was returned with the following conditions: proximal filter sheathed.Articulating distal sheath (ads) relaxed.Distal filter unsheathed.Distal filter slider (#3) detached.During product analysis it was observed that distal filter could not be sheathed / un-sheathed using distal filter slider (#3) due to the detached distal filter slider (#3).The proximal filter could not be unsheathed because it was stuck inside the proximal sheath.

• 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: 17735647
• MDR Text Key: 323305813
• Report Number: 2124215-2023-47136
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/07/2023

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 Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 0031041053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1