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

Catalog Number	OSC-5F-15L/B
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fever (1858); Chills (2191); Foreign Body In Patient (2687)
Date of Event	08/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that an adult female presented to the emergency department with fever, chills, and right lower quadrant abdominal pain post right femoral and umbilical hernia repair with mesh 17 months ago.Three weeks prior to arrival to emergency department, the patient experienced recurrent right inguinal fluid collection and required aspiration and drain in interventional radiology.The drain was removed 4 days prior to emergency department arrival.Ct imaging showed increased size of fluid collection, as well as retained foreign body measuring 1.1 centimeters.The patient underwent robot-assisted foreign body removal and abcess drainage.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed and a root cause could not be determined.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: ONE-STEP¿
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 17857653
• Report Number: 3011642792-2023-00065
• Device Sequence Number: 5930025
• Product Code: GBX
• UDI-Device Identifier: 00884450012079
• UDI-Public: 00884450012079
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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: 06/06/2026
• Device Catalogue Number: OSC-5F-15L/B
• Device Lot Number: I2688491
• 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: 10/10/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female