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

Model Number CMS15-10C

Device Problems Difficult to Remove (1528); Material Integrity Problem (2978); Positioning Problem (3009)

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

Event Date 11/04/2021

Event Type  malfunction  

Event Description

It was reported that the distal filter was removed from the patient in an open state.Procedure summary: a sentinel cerebral protection system (cps) was used during a transcatheter aortic valve implantation (tavi) procedure.The patient anatomy was tortuous.An introducer sheath was placed into the radial artery and the sentinel cps was advanced into position.The proximal filter was deployed into the brachiocephalic artery.The physician attempted to position the distal end of the sentinel cps for distal filter placement however the deflection knob on the handle of the sentinel cps would not transmit movement to the distal end of the sentinel cps.The physician attempted multiple times but was unable to resolve the issue.During removal of the sentinel cps, there was difficulty retracting the proximal filter into the sheath, however, the proximal filter was able to be fully resheathed.While withdrawing the sentinel cps from the patient, the distal filter deployed on its own.The sentinel cps was remove from the patient with the distal filter in an open state.The physician proceeded with the tavi procedure without the sentinel cps.Patient status: there were no patient complications 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; 3636 n. laughlin blvd, suite 1; santa rosa CA 95403
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12846874
• MDR Text Key: 281143203
• Report Number: 2134265-2021-14489
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2022
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 0026310958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Sex: Female