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

Catalog Number 41103510PIG-NB/JP

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

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

Event Date 10/25/2023

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 tevar procedure, a thoracic stent graft was placed, and after the pig tail catheter was brought forward from right femoral artery to the target site along a radifocus guidewire, then angiography was performed.The right fa had calcification.Catheter removal was then attempted post angiography, and it was found that the tip had detached.Detachment was at the level of celiac artery in the ao.The tip migrated to the distal end of the deployed stent graft.The fragment was successfully removed.No additional patient consequences to report.

Manufacturer Narrative

The suspect medical device has been returned for evaluation.The device was visually and microscopically investigated.The complaint is confirmed but 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.

• Brand Name: IMPRESS®
• 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 ; 8012084662
• MDR Report Key: 18038407
• MDR Text Key: 326958876
• Report Number: 3010665433-2023-00075
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450022436
• UDI-Public: 00884450022436
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 41103510PIG-NB/JP
• Device Lot Number: E2334396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2022
• 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
• Patient Outcome(s): Required Intervention