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

Model Number 00884450113868

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2020

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 peripheral vascular procedure, the catheter tip detached within the patient.The physician used a vascular snare device to successfully retrieve the foreign body from the patient.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The 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.Should the device be returned at a later time, the investigation will be re-opened.

• Brand Name: IMPRESS DIAGNOSTIC CATHETER
• Type of Device: INTRAVASCULAR DIAGNOSTIC CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston, tx
• MDR Report Key: 10059723
• MDR Text Key: 191096754
• Report Number: 3010665433-2020-00015
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450113868
• UDI-Public: 00884450113868
• Combination Product (y/n): N
• PMA/PMN Number: K093004
• 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: 04/08/2020

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: 00884450113868
• Device Catalogue Number: 412538BER-H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention