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

Catalog Number	512535VER
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device will not be returning for engineering evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.
Event or Problem Description
The account alleges that during a cerebrovascular intervention procedure, the catheter tip detached within the patient.The physician had acquired arterial access with a guidewire and the 5f catheter.During over-the-wire catheter manipulations under fluoroscopy, after reaching the targeted anatomical site within the cerebral vasculature system the catheter tip detached.The physician was unsuccessful in externalizing the foreign body from the patient and decided to leave the iatrogenic foreign body in-vivo.The patient is currently stable.Health status is improving.No additional consequences to report.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned later, the investigation will be reopened.

• Brand Name: IMPRESS®.BRAIDED CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 17487616
• Report Number: 3010665433-2023-00064
• Device Sequence Number: 7822029
• Product Code: DQO
• UDI-Device Identifier: 00884450032541
• UDI-Public: 884450032541
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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
• Report Date (Section B): 07/28/2023

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: 07/04/2025
• Device Catalogue Number: 512535VER
• Device Lot Number: E2461233
• 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: 07/28/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTERVENTIONAL GUIDEWIRE
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Unknown