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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 Positioning Failure (1158); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation of Vessels (2135)
Event Date 10/08/2021
Event Type  Injury  
Event Description
It was reported that a vessel perforation occurred.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve replacement (tavr) procedure.The proximal filter was deployed in the brachiocephalic artery but it was determined that the positioning was too high in the artery.The proximal filter was recaptured and the sentinel cps was repositioned.The physician attempted to redeploy the proximal filter however, the proximal filter slider on the handle of the sentinel cps would not move.The physician was unable to redeploy the proximal filter.The decision was made to remove the sentinel cps from the patient and begin again with a new device.When removing the sentinel cps from the patient, it became stuck in the 6f radial sheath and a perforation of the radial artery occurred.
 
Manufacturer Narrative
Device evaluated by mfr:visual inspection of the returned device revealed an unknown introducer sheath was attached to the device, the distal filter slider (#3) was bent and the outer shaft/sheath was twisted.The distal filter was sheathed but the condition of the proximal filter could not be confirmed due to the introducer sheath.Microscopic inspection confirmed that the outer shaft/sheath was twisted.The introducer sheath was removed.Functional testing revealed that before flushing the proximal filter was unable to be unsheathed but after flushing the proximal filter was able to be unsheathed.The distal part of the outer shaft/sheath was dissected.Following dissection, wear was found on the forcing braid of the internal part of the outer shaft/sheath (inner shaft/sheath).
 
Event Description
It was reported that a vessel perforation occurred.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve replacement (tavr) procedure.The proximal filter was deployed in the brachiocephalic artery but it was determined that the positioning was too high in the artery.The proximal filter was recaptured and the sentinel cps was repositioned.The physician attempted to redeploy the proximal filter however, the proximal filter slider on the handle of the sentinel cps would not move.The physician was unable to redeploy the proximal filter.The decision was made to remove the sentinel cps from the patient and begin again with a new device.When removing the sentinel cps from the patient, it became stuck in the 6f radial sheath and a perforation of the radial artery occurred.It was further reported that the 6f radial sheath was a non-boston scientific sheath.The patient's condition is good.
 
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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
3636 n. laughlin blvd, suite 1
santa rosa CA 95403
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12668257
MDR Text Key277642024
Report Number2134265-2021-13228
Device Sequence Number1
Product Code PUM
UDI-Device Identifier00863229000004
UDI-Public00863229000004
Combination Product (y/n)N
Reporter Country CodeCA
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 11/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/10/2022
Device Model NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number0025997745
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/10/2020
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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