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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 Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Positioning Problem (3009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2020
Event Type  malfunction  
Event Description
It was reported that the device was unable to be resheathed.The patient's anatomy was tortuous.Radial access was gained and a sentinel cerebral protection system was advanced.The proximal filter was deployed, however, there was difficulty in cannulating the left subclavian artery with the distal filter.They physicians decided to remove the device and upon removal the sentinel system became stuck outside the introducer sheath.It appeared that the proximal filter was not fully retracted.The sentinel system handle was not engaging with the distal end of the device.The sentinel system, introducer sheath and guidewire were removed together.Once removed from the patient, it was noted that the proximal filter was torn.There were no patient complications and the patient status was fine.
 
Manufacturer Narrative
D10 device available for evaluation, returned to manufacturer date - updated h3 device returned to mfr - updated h3 device evaluated by manufacturer: the sentinel device was returned with an unidentified guidewire (not inside the sentinel).The distal filter slider was bent.The outer sheath transition tube was kinked.There were multiple kinks and bents throughout the whole outer sheath length.An introducer sheath was returned stuck on the device and appeared to have been buckled at some point.The tip was not returned.The distal filter membrane was detached from the tip of the tri-layer.The tri-layer was elongated, pinched and twisted.The articulating distal sheath (ads) was flexed and pinched; and felt "bumpy".The outer sheath tip was buckled and beginning to split.The proximal filter was stuck in the outer sheath tip.No inner member damages were visible under the rear handle shells.Flushing was performed through the introducer sheath flush port and removal was attempted, however once it got to the tip it got stuck again.The introducer sheath was cut in order to release the sentinel device; the overall condition of the sentinel device was not altered by the cutting of the introducer sheath.Microscopic inspection of the kinks and damages was taken; wear marks, twisting, pinches and break locations were confirmed.X-ray inspection revealed multiple kinks and bents, matching the location of those in the outer sheath.There was no visible proximal filter damages.The distal filter frame appeared to be kinked.The distal filter coupler was unraveled.The ads damage was confirmed.Due to the condition in which the device was received, no functional tests could be performed.
 
Event Description
It was reported that the device was unable to be resheathed.The patient's anatomy was tortuous.Radial access was gained and a sentinel cerebral protection system was advanced.The proximal filter was deployed, however, there was difficulty in cannulating the left subclavian artery with the distal filter.They physicians decided to remove the device and upon removal the sentinel system became stuck outside the introducer sheath.It appeared that the proximal filter was not fully retracted.The sentinel system handle was not engaging with the distal end of the device.The sentinel system, introducer sheath and guidewire were removed together.Once removed from the patient, it was noted that the proximal filter was torn.There were no patient complications and the patient status was fine.
 
Manufacturer Narrative
B5 describe event or problem: updated.H3 device evaluated by manufacturer: the sentinel device was returned with an unidentified guidewire (not inside the sentinel).The distal filter slider was bent.The outer sheath transition tube was kinked.There were multiple kinks and bents throughout the whole outer sheath length.An introducer sheath was returned stuck on the device and appeared to have been buckled at some point.The tip was not returned.The distal filter membrane was detached from the tip of the tri-layer.The tri-layer was elongated, pinched and twisted.The articulating distal sheath (ads) was flexed and pinched; and felt "bumpy".The outer sheath tip was buckled and beginning to split.The proximal filter was stuck in the outer sheath tip.No inner member damages were visible under the rear handle shells.Flushing was performed through the introducer sheath flush port and removal was attempted, however once it got to the tip it got stuck again.The introducer sheath was cut in order to release the sentinel device; the overall condition of the sentinel device was not altered by the cutting of the introducer sheath.Microscopic inspection of the kinks and damages was taken; wear marks, twisting, pinches and break locations were confirmed.X-ray inspection revealed multiple kinks and bents, matching the location of those in the outer sheath.There was no visible proximal filter damages.The distal filter frame appeared to be kinked.The distal filter coupler was unraveled.The ads damage was confirmed.Due to the condition in which the device was received, no functional tests could be performed.H6 device codes: updated.
 
Event Description
It was reported that the device was unable to be resheathed.The patient's anatomy was tortuous.Radial access was gained and a sentinel cerebral protection system was advanced.The proximal filter was deployed, however, there was difficulty in cannulating the left subclavian artery with the distal filter.They physicians decided to remove the device and upon removal the sentinel system became stuck outside the introducer sheath.It appeared that the proximal filter was not fully retracted.The sentinel system handle was not engaging with the distal end of the device.The sentinel system, introducer sheath and guidewire were removed together.Once removed from the patient, it was noted that the proximal filter was torn.The tip of the device became detached while trying to remove from radial sheath.There were no patient complications and the patient status was fine.It was further reported that the tip of the device was broken off while trying to remove the device from the radial sheath.
 
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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 Key10312724
MDR Text Key200012821
Report Number2134265-2020-09320
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,Followup
Report Date 09/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/17/2021
Device Model NumberCMS15-10C-US
Device Catalogue NumberCMS15-10C-US
Device Lot Number0024954997
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2020
Date Manufacturer Received08/21/2020
Patient Sequence Number1
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