MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER BILIARY DRAINAGE CATHETER LOCKING PIGTAIL 8F X 40CM; STENT, DRAIN

Model Number	755308040E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
Three days after placement, the drainage tube broke and was surgically removed.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.One opened sample was returned from the customer for review.A visual inspection was performed on the returned product.It was observed that the catheter broke near to the radiopaque marker where the two tube are joined.The complaint was confirmed.Training was provided to operators on the relevant procedures.Additionally, the dye was removed, cleaned and adjusted to be in center.Additional information provided in h.3., h.6.And h.11.

• Brand Name: SKATER BILIARY DRAINAGE CATHETER LOCKING PIGTAIL 8F X 40CM
• Common Device Name: STENT, DRAIN
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 22287904
• Report Number: 0001625425-2025-01039
• Device Sequence Number: 20970197
• Product Code: FGE
• UDI-Device Identifier: 00886333006113
• UDI-Public: (01)00886333006113(17)290717(10)11578742
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K073672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 755308040E
• Device Lot Number: 11578742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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: Required Intervention
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian