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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 Difficult to Remove (1528); Device Contamination with Chemical or Other Material (2944); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2023
Event Type  malfunction  
Event Description
It was reported foreign material on the device occurred.A sentinel cerebral protection system (cps) was selected for used in a transcatheter aortic valve replacement (tavr) procedure.During preparation of the sentinel cps, foreign material was noted on the proximal filter that prevented the proximal filter from being sheathed.The sentinel cps was unable to be used for the procedure.No patient complications were reported.
 
Event Description
It was reported foreign material on the device occurred.A sentinel cerebral protection system (cps) was selected for used in a transcatheter aortic valve replacement (tavr) procedure.During preparation of the sentinel cps, foreign material was noted on the proximal filter that prevented the proximal filter from being sheathed.The sentinel cps was unable to be used for the procedure.No patient complications were reported.It was further reported that the foreign material was visualized during the last step of flushing the proximal filter of the sentinel cps under saline.The physicians decided to not use another sentinel cps to complete the procedure.
 
Manufacturer Narrative
H3 device evaluated by mfr.: the returned sentinel cerebral protection system (cps) was received for analysis and analyzed by a bsc quality technician.Visual inspection revealed the proximal filter was unsheathed, the articulating distal sheath was relaxed, the distal filter was unsheathed, the proximal filter was torn.Functional testing revealed the proximal filter of the sentinel cps could be sheathed using proximal filter slider.
 
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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 shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18049076
MDR Text Key327143049
Report Number2124215-2023-60863
Device Sequence Number1
Product Code PUM
Combination Product (y/n)N
Reporter Country CodeCI
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 01/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2023
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 Number0030740282
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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