MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO IMPRESS BRAIDED UTERINE ARTERY CATHETER

Catalog Number	59035IUACTMB-H/B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint cannot be confirmed and a root cause cannot be determined.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were identified.
Event or Problem Description
The account alleges that during the procedure, the tip of the catheter broke and had gone to the popliteal and peroneal artery.While snaring the tip, it broke into several pieces.Thrombolysis was needed to remove the catheter tip from the peroneal artery.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint cannot be confirmed and a root cause cannot be determined.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: IMPRESS BRAIDED UTERINE ARTERY CATHETER
• Common Device Name: UTERINE ARTERY CATHETER
• 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: adrian cole ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 21891997
• Report Number: 3011642792-2025-00050
• Device Sequence Number: 12786698
• Product Code: DQO
• UDI-Device Identifier: 00884450698365
• UDI-Public: 00884450698365
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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: 59035IUACTMB-H/B
• Device Lot Number: I2976280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2024
• 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