MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER DRAINAGE CATHETER - LOCKING PIGTAIL 8F X 35CM

Model Number	755108035
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the percutaneous nephrostomy procedure, the doctor found that the pigtail's suture sleeve and suture strings were leaking bodily fluids.This leakage issue made the doctor very angry because it kept occurring continuously, forcing the doctor to replace the pigtail to solve the problem.Additionally, it caused further harm to the patient.Our customers believe that argon medical does not value this feedback, which is why this poor experience occurs repeatedly every month.The faulty product returned from the hospital included only the pigtail, which was found to be cut into two pieces.A video was provided.
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.
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 and testing were performed on the returned product.The device was tested with argon manufactured syringe for leakage and it was observed that there was leakage from the string hole.Capa ca-00047 has been initiated to address the leakage issue.The capa will document the root cause identified and the corrective action that was taken to address the issue.

• Brand Name: SKATER DRAINAGE CATHETER - LOCKING PIGTAIL 8F X 35CM
• Common Device Name: SKATER
• 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: 20762452
• Report Number: 0001625425-2024-01153
• Device Sequence Number: 18457590
• Product Code: GBO
• UDI-Device Identifier: 00886333000166
• UDI-Public: (01)00886333000166(17270928(11)11440910
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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: 755108035
• Device Lot Number: 11440910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown