MAUDE Adverse Event Report: CLARET MEDICAL, INC. SENTINEL; TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES

Model Number CMS15-10C-US

Device Problems Perivalvular Leak (1457); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Aortic Insufficiency (1715); Stenosis (2263)

Event Date 04/09/2020

Event Type  malfunction  

Event Description

Incident description: distal part of the device came off when the basket could not be retrieved.The filter and distal plastic were stuck.A surgeon was called in and assisted in retrieving the device.Procedural notes:."the right common femoral vein was accessed.A short 6-french sheath was introduced.The right wrist region was anesthetized with 1 ml of xylocaine and the radial artery was accessed and in order to advance a 6-french merit sheath, we had to use a 5-french and 6-french dilator.We then were able to advance a 6-french sheath approximately one-third of the way in.The patient was given a cocktail of nitroglycerin 200 mcg and unfractionated heparin 3000 international units.We then positioned a pigtail catheter in the ascending aorta and aortogram was performed, left anterior oblique position for deployment of the sentinel device.The patient was fully anticoagulated.We now proceeded to advance a diagnostic ima and a j-glidewire into the ascending aorta.We then placed a choice pt wire into the ascending aorta.We then advanced the sentinel device and we were able to engage the left common carotid artery with a choice pt wire, but had difficulties negotiating the distal aspect of the sentinel device into the left common carotid artery itself due to probably calcification and some degree of stenosis.The filter was deployed, but probably just at the origin of the left common carotid artery.We deployed the proximal filter in the innominate artery.We then proceeded to position our pigtail catheter in the noncoronary cusp.Aortography was performed for delineation of landmarks for deployment.We then exchanged out our 8-french sheath for a 14-french esheath that was advanced over a meier wire.The sheath was secured to the skin with nonabsorbable suture.We then advanced a diagnostic al2 and a straight wire, we traversed the aortic valve and did catheter exchanges to place a safari small curve into the left ventricular apex.Under rapid ventricular pacing, we deployed the sapien s3 valve #26.Post-deployment demonstrated trivial to mild eccentric aortic insufficiency.The mean gradient is 5 mmhg.At this juncture, we attempted to retrieve the sentinel device and the distal filter could not be retrieved.The failure of this availability forced us to retrieve the proximal filter and then bring the filter back into the radial artery.When we got to the radial artery, we could not retrieve the system outside the body.We actually consulted vascular surgery, dr.___who suggested that we cut the filter device and introduced a slim 5-french sheath.This was done after multiple attempts were done to try and withdraw the device from the radial artery.Using a slim sheath, we were able to recapture the filter and safely remove it from the access site.".Conclusion: successful under conscious sedation percutaneous transfemoral aortic valve replacement with sapien s3 valve #26.Post-deployment did demonstrate trivial to mild eccentric paravalvular insufficiency with a mean gradient of 5 mmhg.Probably partial deployment of the sentinel device, perhaps not fully covering the left common carotid artery, with difficulties retrieving the distal filter having to remove it at the level of the entry site with a slim sheath 5-french.Successful closure of the right common femoral artery with 2 proglide devices, the left common femoral artery with manual pressure.Right radial artery with a t-band.Discharge summary: "the patient tolerated the procedure well.He was admitted overnight to telemetry for observation.This morning, he is seen resting in bed, offers no complaints and is ready for discharge home.".

• Brand Name: SENTINEL
• Type of Device: TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES
• Manufacturer (Section D): CLARET MEDICAL, INC.; 1745 copperhill pkwy; santa rosa CA 95403
• MDR Report Key: 10042575
• MDR Text Key: 190498330
• Report Number: 10042575
• Device Sequence Number: 1
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: (01)00863229000004(17)220226(10)25293855
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 25293855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31025 DA
• Patient Weight: 106