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

Model Number CMS15-10C-US

Device Problems Difficult or Delayed Positioning (1157); Positioning Problem (3009)

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

Event Date 06/01/2021

Event Type  malfunction  

Event Description

It was reported that failure to maintain proximal filter position occurred.Procedure summary: vascular access for the sentinel cerebral protection system (cps) was obtained via a transradial approach.The sentinel cps was positioned.The physician encountered difficulty deploying the proximal filter in the ascending aorta but was able to be successfully deployed.The physician attempted articulate the distal end of the sentinel cps to place the distal filter in the left common carotid (lcc) artery and encountered difficulty due to the moderately tortuous nature of the right subclavian and innominate arteries.During the articulation attempt to access the lcc, the proximal filter of the sentinel cps moved out of position in an open state.The physician was able to resheath the proximal filter of the sentinel cps.The sentinel cps was repositioned.The physician attempted to redeploy the proximal filter but encountered great difficulty in unsheathing and re-deploying the proximal filter after two attempts.The physician decided to remove the sentinel cps and proceed with the procedure without sentinel cps.Patient status: no patient complications were reported.The patient is well.

Manufacturer Narrative

H3: device eval by manufacturer: the sentinel cerebral protection system was returned with the proximal shaft/sheath slightly buckled near the transition area.The proximal filter was partially un-sheathed, the articulating distal sheath (ads) flexed, and the distal filter un-sheathed.During functional testing, the proximal filter experienced difficulty unsheathing due to the shaft/sheath buckling.

Event Description

It was reported that failure to maintain proximal filter position occurred.Procedure summary: vascular access for the sentinel cerebral protection system (cps) was obtained via a transradial approach.The sentinel cps was positioned.The physician encountered difficulty deploying the proximal filter in the ascending aorta but was able to be successfully deployed.The physician attempted articulate the distal end of the sentinel cps to place the distal filter in the left common carotid (lcc) artery and encountered difficulty due to the moderately tortuous nature of the right subclavian and innominate arteries.During the articulation attempt to access the lcc, the proximal filter of the sentinel cps moved out of position in an open state.The physician was able to resheath the proximal filter of the sentinel cps.The sentinel cps was repositioned.The physician attempted to redeploy the proximal filter but encountered great difficulty in unsheathing and re-deploying the proximal filter after two attempts.The physician decided to remove the sentinel cps and proceed with the procedure without sentinel cps.Patient status: no patient complications were reported.The patient is well.

• 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
• MDR Report Key: 12065959
• MDR Text Key: 258322634
• Report Number: 2134265-2021-08023
• Device Sequence Number: 1
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: 00863229000004
• Combination Product (y/n): N
• PMA/PMN Number: K192460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

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 Expiration Date: 02/12/2023
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0026800839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 08/30/2021
• Supplement Dates FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1