MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. IMPRESS PERIPHERAL CATHETER

Model Number 00884450200018

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a trans jugular liver biopsy procedure, the catheter tip detached within the patient's hepatic vein.The physician acquired antegrade venous access and during catheter manipulations the tip detached.The physician successfully removed the catheter tip with a vascular snare device with no additional consequences to the patient.

Manufacturer Narrative

The device was not returned for evaluation.The complaint could not be confirmed and a root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: IMPRESS PERIPHERAL CATHETER
• Type of Device: PERIPHERAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• MDR Report Key: 9371227
• MDR Text Key: 167856223
• Report Number: 3010665433-2019-00078
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450200018
• UDI-Public: 00884450200018
• Combination Product (y/n): N
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450200018
• Device Catalogue Number: 56538MPA1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE.; GUIDEWIRE
• Patient Outcome(s): Required Intervention