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

Catalog Number 512535HH1

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

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

Event Date 10/09/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The account alleges during a carotid angiography procedure, the catheter broke while still on the wire.The device and detached piece were successfully removed from the patient.No additional patient consequence to report.

Manufacturer Narrative

The suspect medical device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.

• Brand Name: IMPRESS® BRAIDED CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 17958912
• MDR Text Key: 325966788
• Report Number: 3010665433-2023-00089
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450032534
• UDI-Public: 884450032534
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 512535HH1
• Device Lot Number: E2161251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1