MAUDE Adverse Event Report: ARGON MEDICAL DEVICES VSTICK VASCULAR ACCESS SET 5F; V STICK VASCULAR ACCESS SET

Model Number	391505300E
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The wire unraveled will inserted/advanced in to the vein, the wire had to removed.
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
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
Event or Problem Description
The wire unraveled will inserted/avanced in to the vein, the wire had to removed.
Event or Problem Description
The wire unraveled will inserted/avanced in to the vein, the wire had to removed.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.One unsealed sample was returned to argon by the customer for review.A visual inspection was performed on the returned product.The visual inspection established that the coil of the guidewire was stretched out and that the core wire was broken but the weld for the coil was still intact.The damages observed looks to be consistent with pulling on the wire with excessive force.Perhaps the guidewire got caught on something during the procedure and additional force was used to retrieve it.Since the root cause is likely the result of an event within the user's environment, no corrective action will be implemented.

• Brand Name: VSTICK VASCULAR ACCESS SET 5F
• Common Device Name: V STICK VASCULAR ACCESS SET
• 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: 14643737
• Report Number: 0001625425-2022-01019
• Device Sequence Number: 20138526
• Product Code: DYB
• UDI-Device Identifier: 00886333004232
• UDI-Public: 00886333004232
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130730
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2022

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 Model Number: 391505300E
• Device Catalogue Number: 391505300E
• Device Lot Number: 11418661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 05/31/2022; 05/31/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 07/07/2022; 09/12/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown