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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLARET MEDICAL, INC. SENTINEL CEREBRAL PROTECTION SYSTEM (US); EMBOLIC PROTECTION DEVICE
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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 Code Available (3191)
Event Date 01/09/2019
Event Type  Injury  
Event Description
It was reported that removal difficulty occurred resulting in additional intervention.The access site was the right radial.A 6f non boston scientific sheath was used.A sentinel cerebral protection system was inserted and deployed properly.Upon completion of the transaortic valve replacement the sentinel device filters were fully collapsed and as the device was being removed it caught upon the sheath which was kinked.The sentinel could not be removed.Neither the sentinel or sheath broke.The vascular surgeon performed a cutdown while still on the cath lab table; he stated that it was simple and easy.He also stated, "the tip of the sheath looked a little deformed".The patient did well post procedure.
 
Manufacturer Narrative
Device eval by manufacturer: analysis of returned product revealed that the introducer sheath and guidewire are still on the device.Additionally, the distal hypotube is bent, likely from packaging.Due to the hypotube condition, the distal filter was unable to deploy.
 
Event Description
It was reported that removal difficulty occurred resulting in additional intervention.The access site was the right radial.A 6f non boston scientific sheath was used.A sentinel cerebral protection system was inserted and deployed properly.Upon completion of the transaortic valve replacement the sentinel device filters were fully collapsed and as the device was being removed it caught upon the sheath which was kinked.The sentinel could not be removed.Neither the sentinel or sheath broke.The vascular surgeon performed a cutdown while still on the cath lab table; he stated that it was simple and easy.He also stated, "the tip of the sheath looked a little deformed".The patient did well post procedure.
 
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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 Key8281470
MDR Text Key134205765
Report Number2134265-2019-00275
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 04/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2020
Device Model NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number18M12H09
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2019
Date Manufacturer Received03/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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