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 Positioning Failure (1158); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/13/2022
Event Type  malfunction  
Event Description
It was reported that proximal filter dislodgement occurred.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve implantation (tavi) procedure.An introducer sheath was placed into the radial artery and the sentinel cps was advanced and positioned with the proximal filter into brachiocephalic artery.Following deployment of the proximal filter, the proximal filter dislodged from the brachiocephalic artery with the proximal filter in an open state.The proximal filter was recaptured and repositioned in the brachiocephalic artery.However, the proximal filter slider would not advance fully despite applied pressure.The sentinel cps was successfully retrieved and replaced with another sentinel cps to complete the procedure.No patient complications were reported.
 
Event Description
It was reported that proximal filter dislodgement occurred.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve implantation (tavi) procedure.An introducer sheath was placed into the radial artery and the sentinel cps was advanced and positioned with the proximal filter into brachiocephalic artery.Following deployment of the proximal filter, the proximal filter dislodged from the brachiocephalic artery with the proximal filter in an open state.The proximal filter was recaptured and repositioned in the brachiocephalic artery.However, the proximal filter slider would not advance fully despite applied pressure.The sentinel cps was successfully retrieved and replaced with another sentinel cps to complete the procedure.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, a relaxed articulating distal sheath (ads), and an unsheathed distal filter.A microscopic inspection was performed, which did not identify any damage on the inner sheath of the sentinel cps.A functional test was performed and found that before flushing the sentinel cps, the proximal filter could not be unsheathed using the proximal filter slider.After flushing the sentinel cps, the proximal filter was able to be unsheathed using the proximal filter slider, however, there was significant resistance noted.Following deployment of the proximal filter, the proximal filter was found to be torn.A dissection test was performed by creating a transversal cut on the distal part of the outer sheath.No damage was found on the inner sheath following the dissection test.Based upon the information provided the most probable cause is failure to follow instructions.The instructions for use (ifu) states: "contraindications: do not use in vessels with excessive tortuosity".However, the physician states that the tortuosity was severe.That improper use can possibly constrict the inner diameter of the device, causing damages on the proximal filter functionality and integrity.
 
Manufacturer Narrative
B7: other relevant history- corrected the location of severe tortuosity to the subclavian artery as opposed to the previously reported superior cerebellar artery.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, a relaxed articulating distal sheath (ads), and an unsheathed distal filter.A microscopic inspection was performed, which did not identify any damage on the inner sheath of the sentinel cps.A functional test was performed and found that before flushing the sentinel cps, the proximal filter could not be unsheathed using the proximal filter slider.After flushing the sentinel cps, the proximal filter was able to be unsheathed using the proximal filter slider, however, there was significant resistance noted.Following deployment of the proximal filter, the proximal filter was found to be torn.A dissection test was performed by creating a transversal cut on the distal part of the outer sheath.No damage was found on the inner sheath following the dissection test.Based upon the information provided the most probable cause is failure to follow instructions.The instructions for use (ifu) states: "contraindications: do not use in vessels with excessive tortuosity".However, the physician states that the tortuosity was severe.That improper use can possibly constrict the inner diameter of the device, causing damages on the proximal filter functionality and integrity.
 
Event Description
It was reported that proximal filter dislodgement occurred.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve implantation (tavi) procedure.An introducer sheath was placed into the radial artery and the sentinel cps was advanced and positioned with the proximal filter into brachiocephalic artery.Following deployment of the proximal filter, the proximal filter dislodged from the brachiocephalic artery with the proximal filter in an open state.The proximal filter was recaptured and repositioned in the brachiocephalic artery.However, the proximal filter slider would not advance fully despite applied pressure.The sentinel cps was successfully retrieved and replaced with another sentinel cps to complete the procedure.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
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key14940539
MDR Text Key301337732
Report Number2134265-2022-07445
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,Followup
Report Date 05/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/17/2023
Device Model NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number0028403226
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
-
-