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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 Failure to Advance (2524); Defective Device (2588)
Patient Problems Bruise/Contusion (1754); Obstruction/Occlusion (2422)
Event Date 06/22/2021
Event Type  Injury  
Event Description
It was reported that a hematoma and radial artery occlusion occurred.Procedure summary: a sentinel cerebral protection system (cps) was selected and prepared for use in accordance with the instructions for use (ifu).During insertion of the sentinel cps, the sentinel cps kinked and was unable to be positioned.During the procedure, a large hematoma was noted in the patient's upper arm.The hematoma was treated with the application of 15 minutes of pressure and the placement of a blood pressure cuff.A computed tomography (ct) scan of the patient's arm revealed no dissection or pseudo aneurysm or further active bleeding.At an unspecified time, an occlusion within the right radial artery was observed.The procedure was completed using an unknown device.
 
Event Description
It was reported that a hematoma and radial artery occlusion occurred.Procedure summary: a sentinel cerebral protection system (cps) was selected and prepared for use in accordance with the instructions for use (ifu).During insertion of the sentinel cps, the sentinel cps kinked and was unable to be positioned.During the procedure, a large hematoma was noted in the patient's upper arm.The hematoma was treated with the application of 15 minutes of pressure and the placement of a blood pressure cuff.A computed tomography (ct) scan of the patient's arm revealed no dissection or pseudo aneurysm or further active bleeding.At an unspecified time, an occlusion within the right radial artery was observed.The procedure was completed using an unknown device.It was further reported that the access for the sentinel cps was obtained via the right radial artery.The sentinel cps was advanced over a non-boston scientific guide wire positioned from the right radial artery to the ascending aorta.The wire kinked and the sentinel cps was removed.A distal kink was noted on the sentinel cps.A new sentinel cps was advanced over a different non-bsc guidewire.The physician encountered difficulty advancing past the antecubital fossa.The sentinel cps was retracted and readvanced and was able to advance to the ascending aorta.The previously reported hematoma was attributed to gaining access at the access site.The hematoma was noted at the end of the procedure.The following day, computed tomography (ct) imaging revealed no evidence of active arterial bleeding, or pseudoaneurysm formation on the arterial vasculature of right upper limb.There is an occlusion within the right radial artery within the proximal aspect of the forearm.This is more proximal than the usual site of radial access.The radial artery is high rising and tortuous below the elbow so maybe thrombus/dissection related to access or the wire.There is preserved single vessel flow to the right hand via patent ulnar artery.The radial occlusion was resolved with medical therapy.The following day, the patient was discharged from the hospital.
 
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Brand Name
SENTINEL CEREBRAL PROTECTION SYSTEM
Type of Device
EMBOLIC PROTECTION DEVICE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12193518
MDR Text Key262422539
Report Number2134265-2021-08962
Device Sequence Number1
Product Code PUM
Combination Product (y/n)N
PMA/PMN Number
K192460
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/09/2023
Device Model NumberCMS15-10C
Device Catalogue NumberCMS15-10C
Device Lot Number0026781022
Was Device Available for Evaluation? No
Date Manufacturer Received07/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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