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

Catalog Number	512535HH1
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A dhr review was performed and yielded no exception documents that would cause or contribute to the reported failure.A search of the complaint database was performed and only one similar complaint was identified.Should the device be returned later, the investigation will be reopened.
Event or Problem Description
The account alleges that during a carotid artery stenting procedure, the catheter tip detached from its shaft and migrated further into the carotid artery.A vascular snare device was used to capture the detached portion for removal.The foreign body fragmented into smaller pieces.The physician decided to secure the detached fragments, which ment moving towards the cerebral part.The foreign body was pinned in position with a stent.Currently patient is under icu observation for stroke risk.

• Brand Name: IMPRESS®.BRAIDED.CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 14646 kirby dr,; pearland TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 14646 kirby dr,; pearland TX 77047
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 21886844
• Report Number: 3010665433-2025-00018
• Device Sequence Number: 3530550
• Product Code: DQO
• UDI-Device Identifier: 00884450683750
• UDI-Public: 884450683750
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 04/22/2025

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 Expiration Date: 07/07/2025
• Device Catalogue Number: 512535HH1
• Device Lot Number: E2434378
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2022
• 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; Life Threatening
• Patient Sex: Unknown