MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. VESSEL SIZING ANGIOGRAPHIC CATH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 510035AVS20MHK

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  Injury  

Event Description

Catheter being used for arteriogram and broke.Second catheter used and broke.All pieces were able to be retrieved with different catheter.Fda safety report id # (b)(4).

• Brand Name: VESSEL SIZING ANGIOGRAPHIC CATH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.
• MDR Report Key: 11116800
• MDR Text Key: 225338997
• Report Number: MW5098662
• Device Sequence Number: 2
• Product Code: DQO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 12/30/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 510035AVS20MHK
• Device Lot Number: E1938760
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 44