MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. L-CATH PICC 26G (1.9F) 0.60MM X 30CM

Catalog Number 384539

Device Problems Device Slipped (1584); Improper or Incorrect Procedure or Method (2017)

Patient Problems Infiltration into Tissue (1931); Pleural Effusion (2010)

Event Date 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

There were no samples or images available for review and a lot number was not provided.Without the sample to review, a definite root cause and corrective action cannot be established.If the sample is returned at a future date, the complaint will be reopened for further evaluation.Per the clinical education manual that argon maintains, causes related to this issue can be attributed to the handling of the device in the field.Potential causes of pleural effusion include: perforation of subclavian, brachiocephalic, or vena cava veins upon insertion of picc.Erosion of vein due to contact with catheter tip.This may be more likely to occur with left-sided approach from the upper body and the catheter not lying well within the svc.Infusion of hyperosmolar solutions/medications leading to chemical irritation and/or vein thrombosis.More common when tip is against vein wall.Combination of chemical and mechanical trauma to vein leading to erosion and effusion.Picc tip outside of superior vena cava.Blockage of thoracic or lymphatic duct by catheter or thrombus.

Event Description

Picc line that was pulled on a patient who ended up with pleural effusions due to a picc infiltration.

• Brand Name: L-CATH PICC 26G (1.9F) 0.60MM X 30CM
• Type of Device: L-CATH PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 6800514
• MDR Text Key: 83172667
• Report Number: 1625425-2017-00111
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 384539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other