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

Catalog Number	410038MPA1-H/C
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Account report that during a procedure the tip of catheter broke off inside the patient.The tip was retrieved.No significant pressure or torquing was used.No reported patient injury.
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow-up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect medical device was not returned; an evaluation was performed based on the two (2) images provided by the customer.The complaint could not be confirmed.The tip of the device had separated from the body.At the site of separation on the body of the device, the external transition line appears to be within acceptable criteria as specified.The device likely experienced excessive tensile force during use, causing the tip of the device to separate from the body.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.BRAIDED.
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana ines de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 23830628
• Report Number: 1721504-2025-00741
• Device Sequence Number: 9030626
• Product Code: DQO
• UDI-Device Identifier: 00884450787427
• UDI-Public: 00884450787427
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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
• Device Catalogue Number: 410038MPA1-H/C
• Device Lot Number: I3249711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown