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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENTINEL CEREBRAL PROTECTION SYSTEM; EMBOLIC PROTECTION DEVICE
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BOSTON SCIENTIFIC CORPORATION SENTINEL CEREBRAL PROTECTION SYSTEM; EMBOLIC PROTECTION DEVICE Back to Search Results
Model Number CMS15-10C
Device Problems Break (1069); Positioning Failure (1158); Difficult to Remove (1528); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/09/2023
Event Type  malfunction  
Event Description
It was reported that the distal filter was removed in partially open state.Procedure summary: a sentinel cerebral protection system (cps) was used during a transcatheter aortic valve replacement (tavr) procedure.Difficulty was encountered advancing the sentinel cps through the tortuous subclavian artery.The sentinel cps was advanced into position and the proximal filter was successfully deployed.The articulating distal sheath was difficult to flex during placement of the distal filter.When a non-boston scientific guidewire was placed in the carotid artery the physician noted the distal filter slider of the sentinel cps was partly advanced and the distal filter was partially deployed.The distal filter was unable to be fully deployed or resheathed.The procedure was completed with only the proximal filter of the sentinel cps deployed.At the conclusion of the procedure the sentinel cps was removed from the patient with the distal filter in a partially deployed state.Patient status: no patient complications were reported.
 
Manufacturer Narrative
Device technical analysis: the returned device consisted of a sentinel cerebral protection system (cps).Visual analysis of the returned device revealed the proximal and distal filters were sheathed, the articulating distal sheath (ads) was relaxed, and the distal filter slider was kinked.A flow test was performed and the front and rear handle flush ports were able to be flushed without issue.During functional testing, the distal filter failed to deploy using the distal filter slider #3 due to the identified kink.
 
Event Description
It was reported that the distal filter was removed in partially open state.Procedure summary: a sentinel cerebral protection system (cps) was used during a transcatheter aortic valve replacement (tavr) procedure.Difficulty was encountered advancing the sentinel cps through the tortuous subclavian artery.The sentinel cps was advanced into position and the proximal filter was successfully deployed.The articulating distal sheath was difficult to flex during placement of the distal filter.When a non-boston scientific guidewire was placed in the carotid artery the physician noted the distal filter slider of the sentinel cps was partly advanced and the distal filter was partially deployed.The distal filter was unable to be fully deployed or resheathed.The procedure was completed with only the proximal filter of the sentinel cps deployed.At the conclusion of the procedure the sentinel cps was removed from the patient with the distal filter in a partially deployed state.Patient status: no patient complications were reported.
 
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Brand Name
SENTINEL CEREBRAL PROTECTION SYSTEM
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
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17994807
MDR Text Key326367103
Report Number2124215-2023-57801
Device Sequence Number1
Product Code PUM
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K192460
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCMS15-10C
Device Catalogue NumberCMS15-10C
Device Lot Number0031518039
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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