MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MANIFOLD KIT; CARDIOVASCULAR PROCEDURE KIT

Model Number K09-08813

Device Problems Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009); Air/Gas in Device (4062)

Patient Problems Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/14/2022

Event Type  malfunction  

Event Description

Patient came straight to the cath lab for a stemi.Coronary angiography was preformed showing clot in the right coronary artery.Thrombectomy and coronary stenting was preformed successfully.While taking the last picture, air was introduced into the catheter and injected into the patient's rca.The patient started to display stroke symptoms, was put on 100% oxygen and taken to ct for further testing.Air was introduced because the mechanism that stops air from being introduced into the contrast line failed.Investigation revealed the line was not vertical but slightly tilted.Requires staff to remember steps to prevent air, requires tubing to be vertical.

• Brand Name: MANIFOLD KIT
• Type of Device: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 15515219
• MDR Text Key: 300902953
• Report Number: 15515219
• Device Sequence Number: 1
• Product Code: OEZ
• 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: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: K09-08813
• Device Catalogue Number: K09-08813
• Device Lot Number: H2462931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male