MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER INTRODUCER SYSTEM

Model Number	651506300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The 21g puncture needle is vertically inserted into the target catheter, the needle core is withdrawn, and iokesartol is injected.The right hepatic duct is seen to develop and expand, the portal is narrow, and the guide wire is inserted into the human body.It is difficult to find the cavity to enter the common bile duct.The left hepatic duct is explored by b-ultrasound, and 2% lidocaine is given to local anesthesia to the liver surface.It is proposed to conduct ptcd, and the 21g puncture needle is inserted into the target catheter, the needle core is withdrawn, and iokesartol is injected.The left hepatic duct development and expansion are seen to push the dilator along the guide wire, in vivo of patients with broken and delayed guide wires.
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.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.One guidewire was returned for review.The wire was measured at approximately 66 cm.According to the device history record, the wire should have been 80cm in length.The ends of the wire were examined under a microscope and one end of the wire exhibited a straight edge as though the wire had been cut.The other section of the wire was not returned.The most probable cause for the reported issue was most likely the result of an event within the user environment.Most likely the wire was cut by a sharp instrument during the procedure.Since the reported issue was most likely related to the user environment and not a manufacturing error, no corrective action will be taken.Argon will continue to monitor for issues of this nature in the future.
Event or Problem Description
The 21g puncture needle is vertically inserted into the target catheter, the needle core is withdrawn, and iokesartol is injected.The right hepatic duct is seen to develop and expand, the portal is narrow, and the guide wire is inserted into the human body.It is difficult to find the cavity to enter the common bile duct.The left hepatic duct is explored by b-ultrasound, and 2% lidocaine is given to local anesthesia to the liver surface.It is proposed to conduct ptcd, and the 21g puncture needle is inserted into the target catheter, the needle core is withdrawn, and iokesartol is injected.The left hepatic duct development and expansion are seen to push the dilator along the guide wire, in vivo of patients with broken and delayed guide wires.

• Brand Name: SKATER INTRODUCER SYSTEM
• 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: 17566467
• Report Number: 0001625425-2023-01161
• Device Sequence Number: 12436080
• Product Code: GCB
• UDI-Device Identifier: 00886333004515
• UDI-Public: 00886333004515
• 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): 09/22/2023

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: 651506300
• Device Lot Number: 11392139
• 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: 08/01/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2021
• 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