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

Catalog Number 384539

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problems Cardiac Arrest (1762); Death (1802); Pericardial Effusion (3271)

Event Date 02/03/2016

Event Type  Death  

Manufacturer Narrative

Per information received by the sales representative from the customer, this complaint was not due to a product issue. This was a human error in regards to care/maintenance of the picc. An education/training has been scheduled. No additional information was provided by the customer.

Event Description

Notified by customer that there was a bio-patch over the picc insertion site. Four (4) cm of picc migrated inward and patient experienced a pericardial tamponade. Patient died. Per customer, this is not a product issue. This was a human error in regards to care/maintenance of the picc. No other details was provided by the customer. Per medwatch report (b)(4) which was received on march 21, infant had a picc line places on (b)(6) 2016, which has noted to have migrated into the heart and repositioned on two occasions. On (b)(6) 2016 had a sudden arrest and expired. Autopsy revealed a pericardial effusion with fluid consistent with total parenteral nutrition solution. Note: it was confirmed that this medwatch report was the same complaint that we had already received and entered in our complaint database under (b)(4).

• Brand Name: L-CATH 26G (1.9F)0.60MM X 30CM
• Type of Device: L-CATH
• 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: 5539734
• MDR Text Key: 41612920
• Report Number: 1625425-2016-00004
• 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

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 384539
• Device Lot Number: 11122897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/31/2016 Patient Sequence Number: 1