MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER INTRODUCER SYSTEM

Model Number	651506300
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Guidewire in skater set fractured in patient when dilating shealth was advance and remained in patient.Unable to snare the wire at the time.Patient underwent subsequent unsuccessful ct wire localisation and surgical cut down.Wire was finally removed via ureteroscopy.
Additional Manufacturer Narrative
Sample is indicated as available for return.As of the date of this report, sample has not been returned.A follow-up report will be submitted once sample has been returned and reviewed.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.A review of returned product from the customer was performed.Visually inspection of the sample returned from the customer found guidewire tip separated from the wire.During evaluation it was found that excess force was applied causing the wire to break.Wire was measured in dimensions and measured 63 cm instant to 80 cm and 17 cm broken piece of the wire was not returned to argon.Complaint was confirmed.The exact root cause was not determined but the most probable root cause of this issue was either, during manufacturing process tip was not fully welded with the wire or breakage issue was related to an event within the user environment.The supervisor of the area has been notified of this issue and argon will continue to monitor and trend for instances of a similar nature in the future.
Event or Problem Description
Guidewire in skater set fractured in patient when dilating shealth was advance and remained in patient.Unable to snare the wire at the time.Patient underwent subsequent unsuccessful ct wire localisation and surgical cut down.Wire was finally removed via ureteroscopy.

• 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: 15656412
• Report Number: 0001625425-2022-01117
• Device Sequence Number: 17612898
• Product Code: GCB
• UDI-Device Identifier: 00886333004515
• UDI-Public: 00886333004515
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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: 09/01/2022
• Device Model Number: 651506300
• Device Catalogue Number: 651506300
• Device Lot Number: 11380168
• 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: 10/14/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 10/23/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1625425-4/22/20-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown