MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER ALL PURPOSE AND NEPHROSTOMY DRAINAGE SET LOCKING 7F X 25CM; CATHETER, NEPHROSTOMY

Model Number	756607025
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Adhesion(s) (1695)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The drainage catheter was placed in the bile duct of the patient during the period of (b)(6) through (b)(6).The physician attempted to remove the catheter after cutting one thread according to the steps described on the ifu, however, the catheter was not able to be removed.It was possible that the thread was adhered to tissue.He was obliged to cut the catheter shaft to remove the catheter safely from the patient and by that, the catheter was able to be removed somehow.The thread in the inside of the patient was cut very close to the body surface and the thread remained in the body.
Additional Manufacturer Narrative
It is unknown if the sample is available.As of the date of this report, the sample has not been returned.A follow-up report will be submitted upon investigation completion.
Additional Manufacturer Narrative
We conducted a thorough review of the manufacturing and inspection records for this lot and found no deviations or non-conformances.Unfortunately, we did not receive any samples for evaluation, nor did we receive any photographic or visual evidence that would have allowed us to review the allegation in detail.Without this necessary evidence, we are unable to perform a thorough investigation or determine a root cause and corrective action at this time.As a result, no corrective action is required at this point.However, if samples are returned at a later date, we would be happy to reopen this complaint for re-evaluation.

• Brand Name: SKATER ALL PURPOSE AND NEPHROSTOMY DRAINAGE SET LOCKING 7F X 25CM
• Common Device Name: CATHETER, NEPHROSTOMY
• 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: 22307671
• Report Number: 0001625425-2025-01044
• Device Sequence Number: 8705565
• Product Code: GBO
• UDI-Device Identifier: 00886333225118
• UDI-Public: (01)00886333225118(17)290709(10)11579154
• 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,User Facility,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: 756607025
• Device Lot Number: 11579154
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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: Other
• Patient Sex: Unknown