MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING .IMPRESS®.BRAIDED.5F.65 CM.BERENSTEIN..0 SIDE PORTS.0.038"; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	56538BER
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The expired 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 expired device be returned later, the investigation will be reopened.
Event or Problem Description
The customer alleges that during a venogram, the expired catheter tip detached within the patient while removing the catheter over the a guidewire.No additional patient injury to report.

• Brand Name: .IMPRESS®.BRAIDED.5F.65 CM.BERENSTEIN..0 SIDE PORTS.0.038"
• 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: 18040082
• Report Number: 3011642792-2023-00068
• Device Sequence Number: 7222017
• Product Code: DQO
• UDI-Device Identifier: 00884450035948
• UDI-Public: 884450035948
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2023

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: 11/30/2022
• Device Catalogue Number: 56538BER
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2019
• 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: Required Intervention; Other
• Patient Sex: Unknown