MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ARGON PICC CATH FIRST 26GA 1.9 FR 50 CM; CATHETER INTRAVASCULAR

Catalog Number 384232

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Embolism (1829); Foreign Body In Patient (2687)

Event Date 12/22/2018

Event Type  Injury  

Event Description

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 catheter was in from (b)(6) to (b)(6) 2018.The only potential cause attributed to the break could be the infant got her foot wrapped in the line.

• Brand Name: ARGON PICC CATH FIRST 26GA 1.9 FR 50 CM
• Type of Device: CATHETER INTRAVASCULAR
• Manufacturer (Section D): ARGON MEDICAL DEVICES
• MDR Report Key: 8289757
• MDR Text Key: 134904219
• Report Number: MW5083482
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 384232
• Device Lot Number: 11233993
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 DA
• Patient Weight: 5