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

Model Number 00884450668771

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

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

Event Date 05/11/2023

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 a lower leg/sfa arterial angiogram procedures, the black tip of the catheter separated within the patient.Tip separation occurred during [ao run-off] power injections of the lower periphery.The physician used a retrieval basket to successfully liberate the foreign bodies from the patient's vessels.No additional interventions or patient consequences to report.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complain could not be confirmed and a root cause could not be determined.A review of the device history record was performed and one similar complaint for this lot was identfied.

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 one similar complaint for this lot number has been identified.Should the device be returned at a later date, the investigation will be reopened.

• Brand Name: IMPRESS®
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 17027411
• MDR Text Key: 316204968
• Report Number: 3011642792-2023-00041
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450668771
• UDI-Public: 00884450668771
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450668771
• Device Catalogue Number: 46538BER/B
• Device Lot Number: I2573338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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