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

Model Number	391505300E
Health Effect - Clinical Code	Unspecified Vascular Problem (4441)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
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
Patient had a very narrow subclavian vein with clot or stenosis.Wire unravelled as the physician was pulling the wire back/withdrawing the wire.
Event or Problem Description
Patient had a very narrow subclavian vein with clot or stenosis.Wire uravelled as the physician was pulling the wire back/withdrawing the wire.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.One used guidewire was returned to argon from the customer.A visual inspection was performed on the returned sample.The visual inspection established that the coil was stretched out and the core was broken at the taper.The damage is consistent with excessive force being applied to eh wire in a pulling motion.It is likely that the guidewire was pulled back through the needle in which the coils got caught on the edge of the needle and force was use to retrieve it causing breakage of the taper as well as the unraveling of the coil.It is stated in the ifu to not retrieve the wire through the needle.Since this 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: 15445947
• Report Number: 0001625425-2022-01090
• Device Sequence Number: 7511518
• 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
• Report Date (Section B): 11/03/2022

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: 11434600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• 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: 09/01/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 11/04/2022
• 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