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

Catalog Number	46538CB1-H/B
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/24/2025
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 the catheter broke off inside the patient, leaving behind a long plastic fragment with the artery.This was not noticed at the time, but identified on follow up imaging.The patient is awaiting removal of the fragment.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.An x-ray image was provided for revaluation and the customer provided key details regarding the reported issue.It is believed that the device detached in the left deep circumflex iliac artery and later migrated to the aorta.The complaint is confirmed.The root cause could not be determined.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
The suspect device was returned for evaluation.The failure as reported was observed.The tip of the device had separated from the body.The likely root cause of the failure can be attributed to human error.Based on the appearance of the accordion pattern at the site of separation, the device likely experienced excessive tensile force during use which caused the tip of the device to separate from the body.Nonconformances of this nature are monitored by the operation team.This complaint will be used to trend for similar complaints.

• Brand Name: IMPRESS BRAIDED CATHETER
• Common Device Name: PERIPHERAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana inés de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; calle, sor juana inés de la cr; roberto de la madrid; tijuana, b.c. 22630 ; MX 22630
• Manufacturer Contact: adrian cole ; 1600 west merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 22324005
• Report Number: 1721504-2025-00111
• Device Sequence Number: 8794118
• Product Code: DQO
• UDI-Device Identifier: 00884450717936
• UDI-Public: 00884450717936
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K093004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2026

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: 46538CB1-H/B
• Device Lot Number: I3028217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 07/25/2025; 01/14/2026
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/29/2025; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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