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

Device Problems Leak/Splash (1354); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 05/16/2023

Event Type  malfunction  

Event Description

Clear plastic piece above the directional roller had defect, leaking/spraying contrast when injected.Fortunately, they were not injecting the radionuclide yet, changed catheters to a different brand with no issues.We have now pulled all swift ninja's from the shelves after speaking with the physicians.There is a potential for radiopharmaceutical leakage during cases.Following up with the manufacturer regarding quality control.

• Brand Name: MERIT MEDICAL SWIFTNINJA
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.
• MDR Report Key: 16994741
• MDR Text Key: 315968157
• Report Number: MW5117799
• 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: 05/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White