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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); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/08/2022
Event Type  malfunction  
Event Description
It was reported that the proximal filter moved out of position in an open state.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve implantation (tavi) procedure.An introducer sheath was placed into the radial artery and the sentinel cps was advanced and positioned with the proximal filter into brachiocephalic artery.After two deployment attempts, the proximal filter of the sentinel cps was successfully deployed into the brachiocephalic artery.The proximal filter of the sentinel cps moved proximal to the right common carotid artery with the proximal filter in an open state.The proximal filter of the sentinel cps was unable to maintain its correct position.After two attempts to recapture the proximal filter of the sentinel cps, the proximal filter slider on the handle of the sentinel cps became stiff, and it was difficult to fully recapture the proximal filter.The proximal filter of the sentinel cps was able to be fully recaptured prior to removal from the patient.A new sentinel cps was 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, relaxed articulating distal sheath (ads), sheathed distal filter, a kinked distal filter slider (#3), and no damage to the proximal filter slider (#1).A functional test was performed, which found that before flushing the sentinel cps, the proximal filter was unable to be unsheathed using the proximal filter slider (#1).After flushing the sentinel cps, the proximal filter was still unable to be unsheathed using the proximal filter slider (#1).A dissection test was performed using scissors to create a transversal cut on the distal part of the outer shaft.No damage was seen in the inner shaft of the device.
 
Event Description
It was reported that the proximal filter moved out of position in an open state.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve implantation (tavi) procedure.An introducer sheath was placed into the radial artery and the sentinel cps was advanced and positioned with the proximal filter into brachiocephalic artery.After two deployment attempts, the proximal filter of the sentinel cps was successfully deployed into the brachiocephalic artery.The proximal filter of the sentinel cps moved proximal to the right common carotid artery with the proximal filter in an open state.The proximal filter of the sentinel cps was unable to maintain its correct position.After two attempts to recapture the proximal filter of the sentinel cps, the proximal filter slider on the handle of the sentinel cps became stiff, and it was difficult to fully recapture the proximal filter.The proximal filter of the sentinel cps was able to be fully recaptured prior to removal from the patient.A new sentinel cps was used to complete the procedure.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
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 Key15287393
MDR Text Key301921272
Report Number2124215-2022-31713
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 Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/03/2023
Device Model NumberCMS15-10C
Device Catalogue NumberCMS15-10C
Device Lot Number0028320986
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/08/2022
Initial Date FDA Received08/24/2022
Supplement Dates Manufacturer Received09/22/2022
Supplement Dates FDA Received09/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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