MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. FIRST PICC 26GA, SINGLE LUMEN

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/22/2018

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation so the complaint cannot be confirmed.If additional information is provided in the future, this issue will be reevaluated as needed.

Event Description

It was reported that the device, dislodged lower left extremity picc, which has embolized into the right pulmonary artery and overhangs into the right atrium.Piece was retrieved in interventional radiology.The only potential cause that was attributed to the break, could be the infant got her foot wrapped in the line.

• Brand Name: FIRST PICC 26GA, SINGLE LUMEN
• Type of Device: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: gail smith ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 8331072
• MDR Text Key: 135873842
• Report Number: 1625425-2019-00023
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/01/2005,01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2021
• Device Model Number: N/A
• Device Catalogue Number: 384232
• Device Lot Number: 11233993
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 13 DA
• Patient Weight: 5