MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER INTRODUCER SYSTEM

Model Number	651506300
Medical Device Problem Codes	Material Fragmentation (1261); Peeled/Delaminated (1454)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/06/2023
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
During the insertion of the drainage tube, the guide wire was stripped and left in the patient's body, and additional guide wires were used to remove it.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.After three notifications, the sample has not been returned for review, however, images were provided.A review of the provided images was found to be consistent with the reported issue.Therefore, this complaint will be confirmed.The most probable cause for the reported issue was most likely related to an event within the user environment.Possibly the wire was pulled back through the needle as the ifu cautions against.There have been no other complaints regarding this issue with this lot number.Since the reported issue was most likely related to the user environment and not a manufacturing error, no corrective action will be taken at this time.
Event or Problem Description
During the insertion of the drainage tube, the guide wire was stripped and left in the patient's body, and additional guide wires were used to remove it.

• 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: 16690868
• Report Number: 0001625425-2023-01015
• Device Sequence Number: 7347319
• 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): 05/23/2023

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 Catalogue Number: 651506300
• Device Lot Number: 11402341
• 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: 03/27/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown