MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PERFORMA ANGIOGRAPHIC CATHETER - 5F SIM2; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 00884450002469

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687); Vascular Dissection (3160)

Event Date 04/29/2022

Event Type  Injury  

Event Description

During interventional radiology cerebral angiogram the catheter twisted on itself and snapped off into the aorta.It was retrieved but caused a right iliac dissection injury, retroperitoneal hematoma requiring stent placement for repair, and blood products.Fda safety report id# (b)(4).

• Brand Name: PERFORMA ANGIOGRAPHIC CATHETER - 5F SIM2
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; south jordan UT
• MDR Report Key: 14622457
• MDR Text Key: 293562957
• Report Number: MW5110138
• Device Sequence Number: 1
• Product Code: DQO
• 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: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450002469
• Device Catalogue Number: 5576-23
• Device Lot Number: I2298034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 34 YR
• Patient Sex: Female