MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. V¿STICK¿ VASCULAR ACCESS SET; INTRODUCER, CATHETER

Model Number	391505300E
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	09/30/2022
Type of Reportable Event	Serious Injury
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.Manufacturer response for introducer, catheter, v¿stick¿ vascular access set (per site reporter).

• Brand Name: V¿STICK¿ VASCULAR ACCESS SET
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 15671505
• Report Number: 15671505
• Device Sequence Number: 6368666
• Product Code: DYB
• UDI-Device Identifier: 00886333004232
• UDI-Public: (01)00886333004232(17)270427(10)11418661
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/05/2022
• Report Date (Section F): 10/05/2022

1 Device was Involved in the Event

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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 103 KG
• Date Report Sent to FDA: 10/05/2022