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

Model Number	391505300E
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
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 received and reviewed.
Event or Problem Description
Early 40's male with history of ventricular tachycardia.Procedure implantation of cardiac defibrillator during the procedure the distal tip of the argon vascular micro puncture wire broke off and caused an embolism it went from the left subclavian vein to the distal pulmonary arterial system retrieval was attempted in the left femoral vein unsuccessful patient kept the night and discharged the next day asymptomatic.Projected outcome good.Patient asymptomatic.
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
Early 40's male with history of ventricular tachycardia.Procedure implantation of cardiac defibrillator during the procedure the distal tip of the argon vascular micro puncture wire broke off and caused an embolism it went from the left subclavian vein to the distal pulmonary arterial system retrieval was attempted in the left femoral vein unsuccessful patient kept the night and discharged the next day asymptomatic.Projected outcome good.Patient asymptomatic.
Event or Problem Description
Early 40's male with history of ventricular tachycardia.Procedure implantation of cardiac defibrillator during the procedure the distal tip of the argon vascular micro puncture wire broke off and caused an embolism it went from the left subclavian vein to the distal pulmonary arterial system retrieval was attempted in the left femoral vein unsuccessful patient kept the night and discharged the next day asymptomatic.Projected outcome good.Patient asymptomatic update per email: ¿an incision was made over the pulse generator.The old generator was removed from the pocket.The leads were removed from the device and tested.The leads were removed from the pocket and had moderate fibrosis.The rv/icd lead had adequate pacing capture thresholds and sensing.Atrial sensing and capture thresholds were adequate.The left subclavian vein was accessed once over the 1st rib with a micropuncture needle and micropuncture wire after a venogram was performed.Access was difficult due to the existing leads, fibrosis, and changes in anatomy due to longstanding indwelling leads.In the process of trying to achieve access, the tip of the micropuncture wire fractured and embolized, eventually making its way to the rll of the lung.I requested support from my interventional colleagues, and dr scrubbed in and made an attempt to snare the wire fragment using a jl4 and a snare, via an rfv (5fr venous access was obtained under us guidance).The wire fragment was too distal to reach with the snare and was thus abandoned, after deeming the long-term risk of this wire to be low as it will likely endothelialize.A sterile field was maintained throughout the process.¿.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.One used sample was returned to argon from the customer.A visual inspection was performed on the returned product.The visual inspection determined that the tip and the majority of the coil is removed from the guidewire.Upon closer look, there was breakage found on the remainder of the coil.The damages observed looks to be consistent with pulling on the wire with excessive force.Perhaps the guidewire got caught on the needle during the procedure and additional force was used to retrieve it causing breakage of the weld and coil attached.This is warned in the ifu.Ifu pmt-x9585387-0221 states "the guidewire should not be withdrawn through the needle.Damage or shearing of the guidewire may occur." 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: 15741090
• Report Number: 0001625425-2022-01127
• Device Sequence Number: 2868533
• Product Code: DQX
• UDI-Device Identifier: 00886333004232
• UDI-Public: 00886333004232
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 10/25/2022; 10/25/2022
• Initial Report FDA Received Date: 11/05/2022
• Supplement Report FDA Received Date: 03/01/2023; 03/09/2023
• 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: Required Intervention; Life Threatening; Hospitalization; Other
• Patient Sex: Unknown