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

Catalog Number	512538BER
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A supplemental report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that during a tips procedure via radial access through the celiac artery, the catheter tip detached within the patient.The physician had acquired retrograde arterial radial access and during catheter manipulations, the tip fragmented within the patient.The physician attempted to snare the fragments from the patient with a vascular snare device, but the targeted foreign body fragmented again after capture within the patient's vasculature system.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be 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.

• Brand Name: .IMPRESS®.BRAIDED.CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr,; pearland TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr,; pearland TX 77047
• Manufacturer Contact: bryson heaton bsn.rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 18793947
• Report Number: 3010665433-2024-00008
• Device Sequence Number: 20656814
• Product Code: DQO
• UDI-Device Identifier: 00884450009215
• UDI-Public: 884450009215
• 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,Followup
• Report Date (Section B): 02/19/2024

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: 01/17/2025
• Device Catalogue Number: 512538BER
• Device Lot Number: E2321811
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2022
• 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: Other; Hospitalization; Required Intervention
• Patient Sex: Unknown