Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENTINEL CEREBRAL PROTECTION SYSTEM (US); EMBOLIC PROTECTION DEVICE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION SENTINEL CEREBRAL PROTECTION SYSTEM (US); EMBOLIC PROTECTION DEVICE Back to Search Results
Model Number CMS15-10C-US
Device Problems Break (1069); Difficult to Remove (1528); Material Twisted/Bent (2981); Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/07/2023
Event Type  malfunction  
Event Description
It was reported that an inability to resheath the distal filter prior to removal occurred.A sentinel cerebral protection system (cps) was selected for use during a transcatheter aortic valve implantation (tavi) procedure.The radial artery was calcified.An introducer sheath was placed into the radial artery and the sentinel cps was advanced.The proximal filter of the sentinel cps was deployed in brachiocephalic artery and the distal filter was deployed in the left common carotid artery.Upon completion of the tavi procedure, the distal filter could not be recaptured into the catheter.The distal filter hypotube was kinked, and the plastic hub of the distal filter slider was broken.The proximal filter was then successfully recaptured, and the distal filter was removed from the patient in an open state.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the sentinel cps was returned to boston scientific (bsc) and was analyzed by a bsc quality engineer.Visual analysis revealed a sheathed proximal filter, flexed articulating distal sheath, slightly unsheathed distal filter, and a kinked distal filter slider (#3).No additional packaging was returned for analysis.A functional test was performed and found that the distal filter could not be sheathed or unsheathed using the distal filter slider (#3).This inability to sheathe or unsheathe the distal filter was due to the kink in the distal filter slider (#3).
 
Event Description
It was reported that an inability to resheath the distal filter prior to removal occurred.A sentinel cerebral protection system (cps) was selected for use during a transcatheter aortic valve implantation (tavi) procedure.The radial artery was calcified.An introducer sheath was placed into the radial artery and the sentinel cps was advanced.The proximal filter of the sentinel cps was deployed in brachiocephalic artery and the distal filter was deployed in the left common carotid artery.Upon completion of the tavi procedure, the distal filter could not be recaptured into the catheter.The distal filter hypotube was kinked, and the plastic hub of the distal filter slider was broken.The proximal filter was then successfully recaptured, and the distal filter was removed from the patient in an open state.No patient complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key16429062
MDR Text Key310088892
Report Number2124215-2023-08130
Device Sequence Number1
Product Code PUM
UDI-Device Identifier00863229000004
UDI-Public00863229000004
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192460
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/14/2024
Device Model NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number0028867729
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/17/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age68 YR
Patient SexFemale
-
-