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

Model Number CMS15-10C-US

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 11/07/2019

Event Type  malfunction  

Event Description

Sentinel cerebral protection system device opened for use during tavr procedure.During priming for use, the device kept accumulating air bubbles.The physician / surgeon decided to abort using the device.Fda safety report id# (b)(4).

• Brand Name: CEREBRAL PROTECTION SYSTEM
• Type of Device: TEMPORARY CATHETER, EMBOLIC TRANSCATHETER INTRACARDIAC PROCEDURES
• Manufacturer (Section D): CLARET MEDICAL, INC.
• MDR Report Key: 9491015
• MDR Text Key: 171983575
• Report Number: MW5091733
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 19D02H14
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR