MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 20GA (3F) 0.95MM X 65CM; CATHETER INTRAVASCULAR, THERAPEUTIC

Model Number	384156
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	05/17/2025
Type of Reportable Event	Serious Injury
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 placement of a picc, the picc became malpositioned and "flipped towards the shoulder." when repositioning the picc was attempted, the picc fractured, and only 3cm of the catheter came out when extraction was attempted, leaving 28cm in the patient.The patient was taken to the operating room and to the cath lab due to the thrombus, or the portion that remained in the body, in the pulmonary artery.This portion of the catheter was eventually able to be removed and is still being evaluated by pathology at hospital (as of (b)(6)2025).Sample is available.

• Brand Name: FIRST PICC S/L 20GA (3F) 0.95MM X 65CM
• Common Device Name: CATHETER INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 22285535
• Report Number: 0001625425-2025-01035
• Device Sequence Number: 20946955
• Product Code: FOZ
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K972262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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 Expiration Date: 08/31/2026
• Device Model Number: 384156
• Device Lot Number: 11496062
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2025
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown