MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER DRAINAGE CATHETER - LOCKING PIGTAIL 8F X 25CM

Model Number	755108025
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is indicated as available for return.As of the date of this report, sample has not been returned.A follow-up report will be submitted once the sample has been received and reviewed.
Event or Problem Description
The patient's liver abscess was punctured and drained, and the catheter was extubated now.The drainage tube was pulled out smoothly, but the lead was not brought out smoothly.The surgeon was asked to assist in diagnosis and treatment.The resistance was great when trying to pull the lead for many times.Finally, the lead was partially broken and some remained in the patient's body.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.A review of returned product from the customer was performed and visually inspected.The sample returned from the customer had the locking string broken and the complaint was confirmed.Package was open and snap off tab and string was loose inside the package.The most probable root cause could be that user used excessive force or improper anchor during the procedure.The tro-car needle could have advanced to the on position and cut/damaged the string.Since the breakage could be due to an event within the user environment.No corrective action is required at this time.
Event or Problem Description
The patient's liver abscess was punctured and drained, and the catheter was extubated now.The drainage tube was pulled out smoothly, but the lead was not brought out smoothly.The surgeon was asked to assist in diagnosis and treatment.The resistance was great when trying to pull the lead for many times.Finally, the lead was partially broken and some remained in the patient's body.

• Brand Name: SKATER DRAINAGE CATHETER - LOCKING PIGTAIL 8F X 25CM
• Common Device Name: SKATER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 16089825
• Report Number: 0001625425-2023-00918
• Device Sequence Number: 15129838
• Product Code: OAJ
• UDI-Device Identifier: 00886333000159
• UDI-Public: 00886333000159
• Combination Product (Y/N): N
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023
• 2 Devices were Involved in the Event: 1 2

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: 755108025
• Device Catalogue Number: 755108025
• Device Lot Number: 11421909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown