MAUDE Adverse Event Report: ARGON MEDICAL DEVICES 1ST PICC S/L 26GA 1.9F X 50CM CATH

Model Number Z0384232AAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/03/2024

Event Type  Injury  

Event Description

A customer reported on day 8 following implant of a picc line, the patient experienced an interstitial, extravasation injury.The picc was removed intact.Flushed easily with saline solution.No apparent defects with the catheter, upon direct visual inspection.A note from the end user regarding this feedback indicated "there may be other causative factors involved with this particular clinical situation, such as the scalp placement which is not the ideal site of insertion, but acceptable according to manufacturers picc training." radiographic imaging confirmed appropriate catheter tip position, allowing infusion therapy.

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.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no similar concerns were found.One catheter was returned for review.Visual inspection of the sample did not find any damage to the hub or to the catheter tubing.The device was functionally tested and there were no issue found with regards to leakage or occlusion.Argon's education coordinator and clinical consultant was consulted regarding the reported issue from the customer.Per an email from argon's consultant, the following information was provided.If an extravasation injury occurs with a central line, there is either a problem with the hub or the catheter at the point of entry into the body, or there is a fibrin build up along the length of the catheter.In this latter case, the medication enters into the catheter, but since the usual fluid pathway is blocked by the fibrin sheath, the medication or fluid then backs up along the outside of the catheter and exits at skin level.Unfortunately, when the catheter is removed, the fibrin does not come out along with the removed catheter, so you really can¿t see it.The body then reabsorbs the fibrin.Sometimes the fibrin will show up on x-rays prior to the removal of the catheter.It sort of looks like a white, gauzy substance.Another point of clarification is whether this was truly an extravasation or an infiltration? infiltration is simply when fluid leaks into the tissue without any lasting tissue damage whereas extravasation is when the chemical nature of the fluids that leaked into the tissue cause permanent damage to the tissue or tissue death (necrosis).Based on the evaluation of the sample and the information provided by argon's clinical consultant, the most probable cause for the reported issue was most likely related to an event within the user environment and not a manufacturing error.Since a manufacturing defect could not be found, no corrective action will be taken.Argon will continue to monitor for issues of this nature in the future.

• Brand Name: 1ST PICC S/L 26GA 1.9F X 50CM CATH
• Type of Device: 1ST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 18717810
• MDR Text Key: 335521846
• Report Number: 0001625425-2024-00933
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: Z0384232AAL
• Device Lot Number: 11470259
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2024
• 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