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

Model Number CMS15-10C-US

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/29/2022

Event Type  malfunction  

Event Description

It was reported that a device tip detachment occurred.A sentinel cerebral protection system (cps) was prepared for use during a transcatheter aortic valve replacement (tavr) procedure.The sentinel cps was loaded onto a non-boston scientific (bsc) guidewire and advanced towards the radial sheath.Before entering the body of the patient it was observed the distal tip of the sentinel cps was detached from the device.The device was removed from the non-bsc guidewire and a second sentinel cps was used to complete the procedure.No patient complications were reported.

Event Description

It was reported that a device tip detachment occurred.A sentinel cerebral protection system (cps) was prepared for use during a transcatheter aortic valve replacement (tavr) procedure.The sentinel cps was loaded onto a non-boston scientific (bsc) guidewire and advanced towards the radial sheath.Before entering the body of the patient it was observed the distal tip of the sentinel cps was detached from the device.The device was removed from the non-bsc guidewire and a second sentinel cps was used to complete the procedure.No patient complications were reported.

Manufacturer Narrative

H3 device evaluated by mfr: the returned product consisted of a sentinel cerebral protection system (cps) which underwent visual and microscopic inspection.Visual inspection revealed the proximal filter was sheathed, the articulating distal sheath was relaxed, the distal filter was unsheathed, the distal filter slider (#3) was kinked, and the distal tip was detached and not returned.During microscopic inspection a small section of the distal tip tri-layer was found still attached to the coupler.The residual tri-layer bond to the coupler was well adhered.Product analysis confirmed the reported event of tip detachment as the distal tip was not returned with the device.

• 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: 15609528
• MDR Text Key: 306514373
• Report Number: 2124215-2022-40991
• 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: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2024
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0029336791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: White