MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER BILIARY DRAINAGE CATHETER LOCKING PIGTAIL WITH RADIOPAQUE BAND 10F X 40CM

Model Number	755310040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital used a drainage tube to complete biliary puncture and drainage for the patient on (b)(6) 2023.The patient was about to withdraw the tube on (b)(6), but during the angiography, it was found that the drainage tube was broken in two sections.
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 hospital used a drainage tube to complete biliary puncture and drainage for the patient on (b)(6) 2023.The patient was about to withdraw the tube on (b)(6), but during the angiography, it was found that the drainage tube was broken in two sections.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded.After the third notification, the sample was not returned to argon.The complaint was closed.No correction is required at this time.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.

• Brand Name: SKATER BILIARY DRAINAGE CATHETER LOCKING PIGTAIL WITH RADIOPAQUE BAND 10F X 40CM
• 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: 17781402
• Report Number: 0001625425-2023-01197
• Device Sequence Number: 5838421
• Product Code: FGE
• UDI-Device Identifier: 00886333006137
• UDI-Public: 00886333006137
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2023

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 Expiration Date: 06/30/2025
• Device Model Number: 755310040
• Device Lot Number: 11316267
• Was Device Available for Evaluation?: No
• 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: 08/24/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown