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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 to Remove (1528); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/27/2023
Event Type  malfunction  
Event Description
It was reported that the distal filter was removed from the patient in an open state.A transaortic valve replacement (tavr) procedure was being performed.A sentinel cerebral protection system (cps) was advanced with a 0.014 choice extra support guidewire.The proximal filter of the sentinel cps was deployed in the brachiocephalic artery.The articulating sheath was advanced to the left carotid artery (lca) for distal filter placement.Due to the tortuosity of the type ii aortic arch, placement of the 0.014 choice extra support guidewire and distal filter was challenging.The distal filter was deployed, however, fell into the aortic arch.The distal filter was recaptured, and the physician opted to exchange the 0.014 choice extra support guidewire for a non-boston scientific (bsc) guidewire.The non-bsc successfully accessed the lca and the distal filter was deployed a second time.Again, the distal filter shifted, leaving it partially in the ostium of the lca and partially in the aortic arch.In an attempt to reposition the distal filter, resistance was encountered and verification through fluoroscopy revealed the distal filter was stuck.In attempt to re-sheath the distal filter, the distal filter slider was cut.The physician removed the sentinel cps from the patient with the distal filter in an open state.The tavr procedure proceeded without the use of a sentinel cps.The patient awoke from the procedure without complications.
 
Manufacturer Narrative
Device evaluated by mfr.: the sentinel cerebral protection system was returned for analysis.Visual inspection revealed the device to be returned with the proximal filter unsheathed, the articulating distal sheath relaxed, and the distal filter unsheathed.Furthermore, the sentinel cerebral protection system was returned with a guidewire loaded, one portion protruding from the distal filter slider hub, and one portion protruding from the tip.The distal filter slider was observed separated from the handle.The distal filter could not be un-sheathed using the distal filter slider due to the detachment of the distal filter slider from the handle.The type of damage observed via analysis indicates that, with the guidewire already inserted, an excessive force was applied while pulling/pushing the distal filter slider which caused the detachment of it from the handle.Consequently, the distal filter was unable to de deployed/retrieve, thus confirming the reported event.Limited procedural media (i.E.Three filmed sequences of isolated steps within the procedure; no comprehensive recording was available) was provided to aid in the investigation and was reviewed by a bsc medical director.Media review is precluded by image quality and lack of chronological order and time stamps.The first video showed the sentinel device in the circulatory system, with the proximal filter deployed in the brachiocephalic trunk and the distal filter in the aortic arch in between the ostium of the left carotid artery and the left.The 0.014 wire was placed in the left carotid artery, but the system is protruding to the aorta.Speculation can be made regarding the support of the 0.014 guidewire.The second video showed what appears to be unsuccessful attempts to retrieve and re-sheath the distal filter, with the wire distally positioned in the carotid artery.The third video showed the right arm of the patient and it can be seen that an unsheathed distal filter is being pulled back though the lumen of the brachial artery to be withdrawn from the patient apparently with no resistance.No apparent anatomical aspect (aside from a type ii aortic arch) could be identified to cause the protrusion of the system and inability to recapture the distal filter.It could be hypothesized that the low support of the 0.014 guidewire could have played a role in the inability to navigate the distal part though the carotid artery.
 
Event Description
It was reported that the distal filter was removed from the patient in an open state.A transaortic valve replacement (tavr) procedure was being performed.A sentinel cerebral protection system (cps) was advanced with a 0.014 choice extra support guidewire.The proximal filter of the sentinel cps was deployed in the brachiocephalic artery.The articulating sheath was advanced to the left carotid artery (lca) for distal filter placement.Due to the tortuosity of the type ii aortic arch, placement of the 0.014 choice extra support guidewire and distal filter was challenging.The distal filter was deployed, however, fell into the aortic arch.The distal filter was recaptured, and the physician opted to exchange the 0.014 choice extra support guidewire for a non-boston scientific (bsc) guidewire.The non-bsc successfully accessed the lca and the distal filter was deployed a second time.Again, the distal filter shifted, leaving it partially in the ostium of the lca and partially in the aortic arch.In an attempt to reposition the distal filter, resistance was encountered and verification through fluoroscopy revealed the distal filter was stuck.In attempt to re-sheath the distal filter, the distal filter slider was cut.The physician removed the sentinel cps from the patient with the distal filter in an open state.The tavr procedure proceeded without the use of a sentinel cps.The patient awoke from the procedure without complications.
 
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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 Key16497274
MDR Text Key310820855
Report Number2124215-2023-10161
Device Sequence Number1
Product Code PUM
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
K192460
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2023
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 Number0029441067
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/23/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age87 YR
Patient SexFemale
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