MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER DRAINAGE CATHETER - LOCKING PIGTAIL 6F X 25CM

Model Number	755106025
Medical Device Problem Codes	Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
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 needle core could not be pulled out after the renal cyst drainage tube was placed, resulting in a pile of tubes at the end of the drainage tube, and the patient could not be treated after removal.
Event or Problem Description
The needle core could not be pulled out after the renal cyst drainage tube was placed, resulting in a pile of tubes at the end of the drainage tube, and the patient could not be treated after removal.
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.Sample was inspected visually and there were no damages identified on the device.Sample was then functionally tested but metal stiffener and stylet could not be removed due to dry blood and/or body fluid on the device.70% isopropyl alcohol was sprayed on the device and metal stiffener was removed from drainage tube and stylet (tro-car) removed from the metal stiffener without any issue.Product complaint mode could not be duplicate during the evaluation and the complaint was not confirmed.Most likely this issue was related to an event within the user environment, so no further evaluation is needed at this time.No corrective action is required at this time because a manufacturing defect could not be confirmed.

• Brand Name: SKATER DRAINAGE CATHETER - LOCKING PIGTAIL 6F 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: 16628762
• Report Number: 0001625425-2023-01009
• Device Sequence Number: 11899875
• Product Code: GBQ
• UDI-Device Identifier: 00886333000111
• UDI-Public: 00886333000111
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2023

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: 755106025
• Device Catalogue Number: 755106025
• Device Lot Number: 11435894
• 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: 03/14/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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
• Patient Sex: Unknown