MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. ONE-STEP; CATHETER, IRRIGATION

Model Number	00884450012079
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Fever (1858); Chills (2191); Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This is an adult female with history of hernia repair who presented to emergency department (ed) with fever, chills, and abdominal pain.Patient is status post right femoral and umbilical hernia repair with mesh 17 months ago.Post-surgery, the patient experienced recurrent right inguinal fluid collections and had an aspiration and drain placed in interventional radiology 3 weeks before arrival to ed.The drain was removed after 2.5 weeks and she developed fever, chills, and right lower quadrant (rlq) abdominal pain 4 days post removal.Computerized tomography (ct) imaging showed increased size of the fluid collection, as well as a small retained foreign body measuring 1.1 cm.Ultrasound imaging 2 days later revealed similar findings: ¿9 mm echogenic, tubular structure in the right lower quadrant collection.This could represent a fragment of drainage catheter.¿ general surgery consulted to evaluate the patient.The patient underwent robot-assisted foreign body removal and abscess drainage.

• Brand Name: ONE-STEP
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 17842440
• Report Number: 17842440
• Device Sequence Number: 12574607
• Product Code: GBX
• UDI-Device Identifier: 00884450012079
• UDI-Public: (01)00884450012079
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2023
• Report Date (Section F): 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00884450012079
• Device Catalogue Number: OSC-5F-15L/B
• Device Lot Number: 12688491
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 09/25/2023