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

Catalog Number	OSC-5F-10LT/B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
An employee conducted a pmcf review for a drainage catheter.The drainage catheter was used to treat a male patient with a pleural effusion.The primary usage of the device was to facilitate percutaneous drainage of fluids.The literature reviewed alleges that during the use of the drainage centesis catheter a pleural effusion the patient acquired a pneumothorax.No additional info was received for the literature review.No additional patient consequences to report.

• Brand Name: ONE-STEP¿.VALVED CENTESIS CATHETER
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC - MEXICO; 8830 siempre viva rd #100; san diego CA 92104
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC - MEXICO; 8830 siempre viva rd #100; san diego CA 92104
• Manufacturer Contact: adrian cole ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 21471484
• Report Number: 3011642792-2025-00014
• Device Sequence Number: 14325707
• Product Code: GBX
• UDI-Device Identifier: 00884450092606
• UDI-Public: 884450092606
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: OSC-5F-10LT/B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Male