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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 Break (1069); Positioning Failure (1158); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2022
Event Type  malfunction  
Event Description
It was reported that proximal filter damage occurred.A sentinel cerebral protection system (cps) was selected for use during a transcatheter aortic valve implantation (tavi) procedure.The proximal filter of the sentinel cps was deployed.The position of the proximal filter was suboptimal, so the physician elected to reposition the sentinel cps.The proximal filter of the sentinel cps was recaptured, repositioned, and attempted to be redeployed in the brachiocephalic artery.However, the proximal filter slider on the handle of the sentinel cps did not respond, and the proximal filter was not able to be re-deployed.Upon removal from the patient, the proximal filter bag was observed to be separate from the frame of the proximal filter.A new sentinel cps was prepared and successfully used to complete the procedure.No patient complications were reported.
 
Event Description
It was reported that proximal filter damage occurred.A sentinel cerebral protection system (cps) was selected for use during a transcatheter aortic valve implantation (tavi) procedure.The proximal filter of the sentinel cps was deployed.The position of the proximal filter was suboptimal, so the physician elected to reposition the sentinel cps.The proximal filter of the sentinel cps was recaptured, repositioned, and attempted to be redeployed in the brachiocephalic artery.However, the proximal filter slider on the handle of the sentinel cps did not respond, and the proximal filter was not able to be re-deployed.Upon removal from the patient, the proximal filter bag was observed to be separate from the frame of the proximal filter.A new sentinel cps was prepared and successfully used 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), a sheathed distal filter, and a kinked distal filter slider.A functional test was performed and found that the proximal filter was able to be easily unsheathed using the proximal filter slider before flushing of the sentinel cps.
 
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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 Key15229611
MDR Text Key302018982
Report Number2134265-2022-08501
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 09/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/25/2024
Device Model NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number0028739660
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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