MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PERFORMA®; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 00884450026984

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

Team was using the power injector to inject the aorta during a thoracic aorta stent graft implantation procedure.We did this through a 5french 100cm merit medical marking pigtail catheter (ref 510035avs20pig; lot# e2149332).During an injection we noticed that the catheter had broken in two inside of the patient's descending thoracic aorta.Manufacturer response for marking pigtail catheter, (brand not provided) (per site reporter).Doctor involved in the event relayed information to vendor reps.

• Brand Name: PERFORMA®
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 13059266
• MDR Text Key: 282613477
• Report Number: 13059266
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450026984
• Device Catalogue Number: 510035AVS20PIG
• Device Lot Number: E2149332
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Race: White