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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 Positioning Failure (1158); Defective Device (2588); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2023
Event Type  malfunction  
Event Description
It was reported that a proximal filter dislodgement occurred.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve implantation (tavi) procedure.The vessels were mildly tortuous and there was no significant calcium in the right subclavian artery.The activated clotting time of the patient was over 250 seconds before insertion of the sentinel cps.An introducer sheath was placed into the radial artery and the sentinel cps was advanced and positioned with the proximal filter into brachiocephalic artery.The activated clotting time of the patient remained over 250 seconds after insertion of the sentinel cps.The proximal filter was successfully deployed into the brachiocephalic artery.Upon cannulating to the left common carotid artery with the articulating distal sheath, the proximal filter dislodged from the brachiocephalic artery in an open state.The proximal filter was recaptured and repositioned in the brachiocephalic artery.However, the proximal filter slider exhibited stiffness, and the proximal filter would not open.The sentinel cps was successfully retrieved, and the procedure was completed without a sentinel cps in place.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, relaxed articulating distal sheath (ads), and unsheathed distal filter.A functional test was performed, which found that the proximal filter could be successfully deployed using the proximal filter slider (#1).A flow test was successfully performed through the front handle flush port, rear handle flush port, and distal filter slider flush port.
 
Event Description
It was reported that a proximal filter dislodgement occurred.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve implantation (tavi) procedure.The vessels were mildly tortuous and there was no significant calcium in the right subclavian artery.The activated clotting time of the patient was over 250 seconds before insertion of the sentinel cps.An introducer sheath was placed into the radial artery and the sentinel cps was advanced and positioned with the proximal filter into brachiocephalic artery.The activated clotting time of the patient remained over 250 seconds after insertion of the sentinel cps.The proximal filter was successfully deployed into the brachiocephalic artery.Upon cannulating to the left common carotid artery with the articulating distal sheath, the proximal filter dislodged from the brachiocephalic artery in an open state.The proximal filter was recaptured and repositioned in the brachiocephalic artery.However, the proximal filter slider exhibited stiffness, and the proximal filter would not open.The sentinel cps was successfully retrieved, and the procedure was completed without a sentinel cps in place.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 Key17817841
MDR Text Key324262636
Report Number2124215-2023-49220
Device Sequence Number1
Product Code PUM
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K192460
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2023
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 Number0030516935
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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