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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENTINEL CEREBRAL PROTECTION SYSTEM (US); EMBOLIC PROTECTION DEVICE
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BOSTON SCIENTIFIC CORPORATION SENTINEL CEREBRAL PROTECTION SYSTEM (US); EMBOLIC PROTECTION DEVICE Back to Search Results
Model Number CMS15-10C-US
Device Problems Difficult to Remove (1528); Defective Device (2588); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2023
Event Type  malfunction  
Event Description
It was reported that the distal filter was removed from the patient in an open state.A sentinel cerebral protection system (cps) was being used for a transcatheter aortic valve replacement (tavr) procedure.The sentinel cps was inserted; however, difficulty was encountered when attempting to access the left carotid artery, possibly due to the angulation of the patient anatomy.Furthermore, when removing the system, it was not possible to advance the distal filter slider, thus, preventing the distal filter from opening.A new sentinel cps was prepared, inserted, and positioned without difficulty.A non-boston scientific (bsc) tavr delivery system (ds) was inserted.While the non-bsc tavr ds crossed the aortic arch, it interacted with the sentinel cps, pulling it into the ascending aorta.The sentinel cps was noted to be damaged and unable to be used for the procedure.The physician attempted retracting the slider to close the filter, however the slider was damaged, preventing the filter from recapturing.The sentinel cps was removed from the patient in the open state.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the sentinel cerebral protection system was returned for analysis.Upon visual inspection, the sentinel cerebral protection system returned with the proximal filter sheathed, the articulating distal sheath relaxed, the distal filer sheathed, and the distal filter slider kinked.A functional test was performed which revealed the distal filter sheath could not be un-sheathed using the distal filter slider due to the kink in the distal filter slider.The visualized kink in the distal filter slider is consistent with excessive force applied while pulling/pushing the distal filter slider.Device analysis confirmed the reported failure to capture/retrieve the distal filter.
 
Event Description
It was reported that the distal filter was removed from the patient in an open state.A sentinel cerebral protection system (cps) was being used for a transcatheter aortic valve replacement (tavr) procedure.The sentinel cps was inserted; however, difficulty was encountered when attempting to access the left carotid artery, possibly due to the angulation of the patient anatomy.Furthermore, when removing the system, it was not possible to advance the distal filter slider, thus, preventing the distal filter from opening.A new sentinel cps was prepared, inserted, and positioned without difficulty.A non-boston scientific (bsc) tavr delivery system (ds) was inserted.While the non-bsc tavr ds crossed the aortic arch, it interacted with the sentinel cps, pulling it into the ascending aorta.The sentinel cps was noted to be damaged and unable to be used for the procedure.The physician attempted retracting the slider to close the filter, however the slider was damaged, preventing the filter from recapturing.The sentinel cps was removed from the patient in the open state.No patient complications were reported.
 
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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 Key16354197
MDR Text Key309381107
Report Number2124215-2023-04864
Device Sequence Number1
Product Code PUM
UDI-Device Identifier00863229000004
UDI-Public00863229000004
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K192460
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number0029469918
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/25/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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