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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 or Delayed Positioning (1157); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2024
Event Type  malfunction  
Event Description
It was reported that device failure recapture occurred.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve replacement (tavr) procedure.During a recapture attempt, the proximal filter became stuck and was unable to be fully resheathed.The sentinel cps was removed and the procedure was completed with a second sentinel cps.No patient complications were reported.
 
Manufacturer Narrative
B5 describe event or problem updated e1 initial reporter title updated e1 initial reporter first name updated e1 initial reporter last name updated h6 device codes updated.
 
Event Description
It was reported that device failure recapture occurred.A sentinel cerebral protection system (cps) was used during a transcatheter aortic valve replacement (tavr) procedure.During a recapture attempt, the proximal filter became stuck and was unable to be fully resheathed.The sentinel cps was removed and the procedure was completed with a second sentinel cps.No patient complications were reported.It was further reported difficulty deploying the proximal filter occurred.
 
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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 Key18610329
MDR Text Key335083640
Report Number2124215-2024-03954
Device Sequence Number1
Product Code PUM
Combination Product (y/n)N
Reporter Country CodeTW
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 02/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2024
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 Number0032047022
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/04/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/19/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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