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

Model Number CMS15-10C-US

Device Problems Break (1069); Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/18/2019

Event Type  malfunction  

Event Description

The wire was attempted to be placed through the device but it came to a hard stop and would not advance.A second device was used and due to tortuosity, the distal filter could not be advanced into the carotid artery and it plopped into the aorta, and while trying to re sheath the filter, the handle on the device broke off.The device was removed without difficulties or injury to the patient.No sentinel was used for the patient.

• 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: 9255628
• MDR Text Key: 164299574
• Report Number: 9255628
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2019,09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• 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: 19H01H21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2019
• Event Location: Other
• Date Report to Manufacturer: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1