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

Model Number	384516
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Reporter indicated picc line severed on insertion and a portion was retained by the patient.No deviations in the proper use of the equipment were identified from our review.Picc catheter checked prior to insertion, 1.2 fr l-cath, length = 25 cm.Picc catheter being inserted via lt saphenous vein, resistance noted at groin area, slow extraction of catheter done and observed guide wire being visible.Catheter marking 15.5 cm where guide wire is visible, original catheter length 25 cm.Most responsible physician called immediately.Stat x-ray done, catheter visible in lt leg, igt contacted immediately.Ultrasound done by igt fellow and plans made for removal.Of note, the retained portion was removed without complication or further harm to the infant.
Additional Manufacturer Narrative
The sample was returned to argon for investigation.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.One opened catheter was returned for review.Visual inspection found the catheter tubing to be in two pieces.One piece was still attached to the catheter hub.A review of the breakage area of both tubing pieces found the area to have a straight angled surface as though the tubing had been cut.The most probable cause for the reported issue was most likely related to an event within the user environment.Possibly the catheter came in contact with a sharp instrument resulting in the damage to the catheter tubing.There have been no other complaints regarding this issue with this lot number.Since the reported issue was most likely related to an event within the user environment and not a manufacturing error, no corrective action will be taken at this time.Argon will continue to monitor for issues of this nature in the future.

• Brand Name: L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN)
• Common Device Name: L-CATH PICC
• 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: 21316129
• Report Number: 0001625425-2025-00929
• Device Sequence Number: 8564143
• Product Code: LJS
• UDI-Device Identifier: 00886333209910
• UDI-Public: (01)00886333209910(17)271001(10)11600231
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: 11600231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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