Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLARET MEDICAL, INC. SENTINEL CEREBRAL PROTECTION SYSTEM (US); EMBOLIC PROTECTION DEVICE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CLARET MEDICAL, INC. SENTINEL CEREBRAL PROTECTION SYSTEM (US); EMBOLIC PROTECTION DEVICE Back to Search Results
Model Number CMS15-10C-US
Device Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/04/2020
Event Type  malfunction  
Event Description
It was reported that an inability to fully resheath the proximal filter occurred.A sentinel cerebral protection system was used during a transcatheter aortic valve replacement (tavr) procedure.At the end of the procedure, the proximal filter was unable to be resheathed.It was removed from the patient in a partially resheathed state.There were no patient complications reported.
 
Manufacturer Narrative
H3: device eval by manufacturer: the device was received by boston scientific(bsc) and reviewed by a bsc quality engineer.Analysis of the returned product revealed that the proximal filter could not be sheathed due to excess dried blood/thrombus/debris in the shaft and proximal filter of the catheter.Additionally, a distal filter slider (#3) kink was detected.In addition, the proximal filter was able to be sheathed/un-sheathed after flushing and removal of dried blood/thrombus/debris.
 
Event Description
It was reported that an inability to fully resheath the proximal filter occurred.A sentinel cerebral protection system was used during a transcatheter aortic valve replacement (tavr) procedure.At the end of the procedure, the proximal filter was unable to be resheathed.It was removed from the patient in a partially resheathed state.There were no patient complications reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SENTINEL CEREBRAL PROTECTION SYSTEM (US)
Type of Device
EMBOLIC PROTECTION DEVICE
Manufacturer (Section D)
CLARET MEDICAL, INC.
1745 copperhill parkway
santa rosa CA 95403
MDR Report Key10421255
MDR Text Key203357639
Report Number2134265-2020-11261
Device Sequence Number1
Product Code PUM
UDI-Device Identifier00863229000004
UDI-Public00863229000004
Combination Product (y/n)N
PMA/PMN Number
DEN160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/26/2022
Device Model NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number0025293855
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2020
Date Manufacturer Received10/19/2020
Patient Sequence Number1
-
-