MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT MAESTRO MIRCOCATHETER; CATHETER, CONTINUOUS FLUSH

Model Number 28M2411045

Device Problem Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 04/27/2023

Event Type  malfunction  

Event Description

We had a patient come to us in er with bleeding.We put micro cath in patient and deployed first coil 30cm and it deployed just fine.We then got a longer coil 60cm and it would not advance into the cath.We retrieved and flushed the micro cath multiple times and tried a new 60cm coil with the same result.We then removed micro cath and exchanged for a larger micro cath and used different larger coils with no issues.Everything ended well.Reference report #mw5117288.

• Brand Name: MERIT MAESTRO MIRCOCATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.
• MDR Report Key: 16886519
• MDR Text Key: 314849968
• Report Number: MW5117287
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/28/2023

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 Expiration Date: 01/30/2024
• Device Model Number: 28M2411045
• Device Lot Number: H2162033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male