MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING IMPRESS®.BRAIDED; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 58038MIK

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

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

Event Date 03/12/2024

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return 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 later, the investigation will be reopened.

Event Description

The account alleges that during a vascular procedure, it was noted that the tip of the catheter detached within the patients body.A vascular snare device was used to retrieve the foreign body from the patient.No additional patient consequences to report.

• Brand Name: IMPRESS®.BRAIDED
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr,; pearland TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr,; pearland TX 77047
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012088662
• MDR Report Key: 19122052
• MDR Text Key: 340336450
• Report Number: 3010665433-2024-00014
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450009420
• UDI-Public: 884450009420
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2024

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 Catalogue Number: 58038MIK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention