MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN; CATHETER INTRAVASCULAR, THERAPEUTIC

Model Number	384516
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
Reporter stated "picc catheter advanced through introducer.Resistance met.As catheter was retracted, noted catheter had broken off and guidewire was exposed.Remainder of catheter removed, chest x-ray obtained.Catheter fragment noted and infant transferred to chom for removal of retained fragment.".
Additional Manufacturer Narrative
After thoroughly reviewing the manufacturing and inspection records for this lot, we found no deviations or non-conformances.Based on the product experience report, it appears there was no sample available for return.Additionally, we did not receive any photographic or visual evidence that would have allowed us to further review your concern.Unfortunately, without the necessary evidence, we are unable to conduct a thorough investigation at this time.As a result, determining the root cause and corrective action is not feasible.If samples become available in the future, the complaint can be reopened for investigation.As there is no clear evidence suggesting that the product was manufactured incorrectly, no corrective actions will be implemented at this time.Argon remains committed to monitoring the issue closely to address any potential future occurrences.Additional information provided in h.6.And h.11.

• Brand Name: L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN
• 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: 21877170
• Report Number: 0001625425-2025-00993
• Device Sequence Number: 7864800
• Product Code: LJS
• UDI-Device Identifier: 00886333209910
• UDI-Public: (01)00886333209910(17)270910(10)11599264
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230669
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: 384516
• Device Lot Number: 11599264
• Was Device Available for Evaluation?: No
• 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: 03/24/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2024
• 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