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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 Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2021
Event Type  malfunction  
Event Description
It was reported that a failure to resheath the proximal filter occurred.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve replacement (tavr) procedure.The brachiocephalic anatomy was noted to be tortuous.The sentinel cps was advanced into position and the proximal filter was successfully deployed.Due to the vessel tortuosity, the physician was unable to suitably position the distal end of the sentinel cps for distal filter deployment.The physician recaptured the proximal filter and repositioned the sentinel cps.The proximal filter was redeployed; however, the physician was still unable to suitably position the distal end of the sentinel cps for distal filter deployment.The physician attempted to recaptured the proximal filter but was unable to fully resheath the proximal filter.The sentinel cps was removed from the patient with the proximal filter in an unsheathed state.No patient complications were reported.The patient is ok.
 
Manufacturer Narrative
The returned device consisted of a sentinel cerebral protection system.Visual inspection of the returned device revealed the proximal filter was partially unsheathed and torn.The distal filter was sheathed.The articulating distal sheath was flexed and the distal filter slider was kinked.During functional testing the articulating distal sheath (ads) was able to be relax using articulation knob (#2) and the proximal filter was unable to be unsheathed using the proximal filter slider (#1).After flushing the proximal filter was able to be unsheathed using proximal filter slider (#1).After deployment the proximal filter was found torn.Using scissors, a transversal cut was performed on the distal part of the outer shaft/sheath.After the cut, a wear was found on the forcing braid of the internal part of the outer shaft/sheath (inner shaft/sheath).Also, multiple holes were found on the proximal filter.
 
Event Description
It was reported that a failure to resheath the proximal filter occurred.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve replacement (tavr) procedure.The brachiocephalic anatomy was noted to be tortuous.The sentinel cps was advanced into position and the proximal filter was successfully deployed.Due to the vessel tortuosity, the physician was unable to suitably position the distal end of the sentinel cps for distal filter deployment.The physician recaptured the proximal filter and repositioned the sentinel cps.The proximal filter was redeployed; however, the physician was still unable to suitably position the distal end of the sentinel cps for distal filter deployment.The physician attempted to recaptured the proximal filter but was unable to fully resheath the proximal filter.The sentinel cps was removed from the patient with the proximal filter in an unsheathed state.No patient complications were reported.The patient is ok.
 
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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
2546 calle primera
alajuela
CS  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12550603
MDR Text Key274000817
Report Number2134265-2021-12173
Device Sequence Number1
Product Code PUM
UDI-Device Identifier00863229000004
UDI-Public00863229000004
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192460
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/19/2021
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 Date04/14/2023
Device Model NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number0027141487
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/15/2021
Initial Date FDA Received09/29/2021
Supplement Dates Manufacturer Received11/03/2021
Supplement Dates FDA Received11/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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