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

Model Number CMS15-10C-US

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/19/2020

Event Type  malfunction  

Event Description

Incident description: while attempting to place sentinel device in patient, the device "broke" per md.Device removed.Notes from the procedure: "we advanced the pigtail catheter in the ascending aortic arch and performed an aortogram.We then advanced our diagnostic ima catheter and positioned it in the ascending aorta through the right radial access.We then placed a choice pt wire and then advanced the sentinel device.We deployed the distal filter in the left ____ artery and the proximal filter in the innominate artery.We had to use a second device because the first device failed step two, not able to flex the sentinel device.The second device, however, sat very nicely.We then positioned our pigtail catheter in the right coronary cusp." there were no complications noted.Conclusion: successful conscious sedation, percutaneous transfemoral aortic valve replacement with sapien s3 valve #23.Additional 2 ml of volume was utilized.Post-deployment demonstrated mean gradient of 5 mmhg.No perivalvular insufficiency.Successful deployment and retrieval of the sentinel device.Successful closure of the left common femoral artery with two proglide devices and the right common femoral artery with a 6-french angio-seal device.Good hemostasis obtained at the radial access with t band.Manufacturer response for temporary catheter, embolic protection, transcatheter intracardiac procedures, sentinel (per site reporter).They provided a shipper kit to return the device, for their analysis.

• Brand Name: SENTINEL
• Type of Device: TEMPORARY CATHETER, EMBOLIC PROTECTION, TRANSCATHETER INTRACARDIAC PROCEDURES
• Manufacturer (Section D): CLARET MEDICAL, INC.; 1745 copperhill pkwy; suite 1; santa rosa CA 95403
• MDR Report Key: 10024136
• MDR Text Key: 189867182
• Report Number: 10024136
• Device Sequence Number: 1
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: (01)00863229000004(17)220127(10)25119281
• 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: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• 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: 25119281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29930 DA
• Patient Weight: 96