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

Catalog Number	46535RIM/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that a vascular surgeon was performing a leg angiogram; while removing the catheter from the femoral artery, the tip of the catheter broke off.A snare device was used to retrieve and remove the catheter tip from the patient.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed.The root cause is attributed to human factors specifically, an error during the fusion process involving the sleeve interface.Improper technique during this critical step resulted in incomplete fusion between components, ultimately leading to detachment during use.Quality and manufacturing have been made aware of the issue.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.
Additional Manufacturer Narrative
Tan updated investigation determined the failure mode of tip elongation as the detached tip exhibited a slightly elongated shape with a shredded appearance.The fusion area between the shaft and the tip was intact and clearly visible during inspection.The detached tip was securely trapped within the snare loop catheter, confirming the reported issue.The exact origin of the reported damage could not be definitively determined; improper handling or patient anatomy may result in stretching or deforming the catheter leading to elongation.Catheter elongation is likely due to excessive force during the procedure rather than a manufacturing issue.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.
Additional Manufacturer Narrative
This supplemental report is submitted to correct the previously documented investigation findings and conclusion.Upon additional review of the complaint record it was observed that the failure mode should be updated from tip detachment to tip elongated/broke to more accurately describe the observed condition.This change triggered additional review and evaluation of the two returned units.One unit exhibited a separated distal tip segment that appeared elongated and shredded; however, the fusion bond between the catheter shaft and tip remained intact aligning with the change in failure mode of the complaint record.The detached tip segment was found within the snare catheter that was returned with the devices.No abnormalities were identified in the second unit.A definitive root cause for the elongated segment could not be determined.The intact fusion zone and appearance of the detached tip segment are not consistent with a manufacturing defect.Tip elongation and separation can occur if excessive force is applied during withdrawal; particularly when navigating restrictive anatomy.Review of the device history record identified no nonconformances, and tensile testing performed demonstrated that the lot met all specifications at the time of manufacture.Manufacturing and quality have been notified, and the event will continue to be monitored through merit's post-market surveillance processes.

• Brand Name: IMPRESS®
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012084225
• MDR Report Key: 22660600
• Report Number: 1721504-2025-00202
• Device Sequence Number: 19752217
• Product Code: DQO
• UDI-Device Identifier: 00884450038192
• UDI-Public: 00884450038192
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/16/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 46535RIM/B
• Device Lot Number: I3141443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 12/01/2025; 12/04/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/02/2025; 12/02/2025; 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown