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 04/23/2020

Event Type  malfunction  

Event Description

Incident description: device malfunction; "2" knob on sentinel device broke during deployment.The procedure was carried out with no complications.Conclusion: successful conscious sedation, percutaneous transfemoral aortic valve replacement with sapien s3 valve #29 minus 1 ml of volume.Mean gradient of 5 mmhg with no perivalvular insufficiency.Successful placement and retrieval of the sentinel device and the patient had a bovine arch.Successful shockwave therapy of the right common iliac artery with a 7 mm balloon.Successful closure of the right common femoral artery with 2 proglide devices, the left common femoral artery with a 6-french angio-seal device, and a t-band for the radial access.Manufacturer response for temporary catheter, embolic protection, transcatheter intracardiac procedures, sentinel (per site reporter).Spoke with rep; will send the device back for analysis.

• 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: 10042482
• MDR Text Key: 190494231
• Report Number: 10042482
• 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: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/30/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Weight: 102