MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER ALL-PURPOSE AND NEPHROSTOMY SET LOCKING 8FR X 25CM

Model Number	756608025
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Event or Problem Description
The patient comes for a check-up due to wet dressings around the nephrostomy.It turns out that the leak is from the catheter's white connector itself and not between the catheter and the collection the hose.Decision on change.Gidewire are inserted into the renal pelvis.When the catheter is extracted, bleeding from the catheter hole is obtained.The catheter was changed to a 10 french catheter minipigtail, thus a size larger than before to possibly tamponade the bleeding.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.According to the customer, after third notification, sample was not returned to argon.The complaint was closed.No corrective required at this time.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.
Event or Problem Description
The patient comes for a check-up due to wet dressings around the nephrostomy.It turns out that the leak is from the catheter's white connector itself and not between the catheter and the collection the hose.Decision on change.Gidewire are inserted into the renal pelvis.When the catheter is extracted, bleeding from the catheter hole is obtained.The catheter was changed to a 10 french catheter minipigtail, thus a size larger than before to possibly tamponade the bleeding.

• Brand Name: SKATER ALL-PURPOSE AND NEPHROSTOMY SET LOCKING 8FR 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: 16457112
• Report Number: 0001625425-2023-00979
• Device Sequence Number: 19419040
• Product Code: GBO
• UDI-Device Identifier: 00886333217786
• UDI-Public: 00886333217786
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023
• 2 Devices were Involved in the Event: 1 2

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: 756608025
• Device Catalogue Number: 756608025
• Device Lot Number: 11445210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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: Required Intervention; Other
• Patient Sex: Unknown