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

Catalog Number 46535BER/B

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

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

Event Date 09/13/2023

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 the black tip of the braided 4 fr catheter detached while inside the patient.It took some time to retrieve the tip with a retrieval catheter.No additional details to report.

Manufacturer Narrative

The suspect device was returned for evaluation.The complaint was confirmed.The returned sample evaluation concluded that the tip and body detachment during final use are similar failure mode as weak fuse joint, and potentially rollflex inspection escapes.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: IMPRESS®
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 17770295
• MDR Text Key: 323682502
• Report Number: 3011642792-2023-00058
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450668115
• UDI-Public: 00884450668115
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 46535BER/B
• Device Lot Number: I2700257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2023
• 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