MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 28GA (1.2F) X 25CM

Model Number 28 GA (1.2F) X 25CM

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

The sample is expected to return for evaluation. A follow-up report will be submitted once the sample has been received and reviewed.

Event Description

Second picc line to get stuck inside the same baby. The first having broken in the saphenous vein and being the subject of complaint (b)(4). The picc line of the current complaint remained stuck in the left cephalic vein. Unsuccessful attempt at post-technical alteplase withdrawal. Consultations in vascular surgery and pediatric cardiology, cariac ultrasound and doppler performed. Picc removed in a hemodynamic room under fluoroscopy with a pediatric cardiology team. So many investigations / consultations. Parental concerns since the removal of the first incarcerated picc line required vascular surgery and general anesthesia.

• Brand Name: L-CATH PICC S/L 28GA (1.2F) X 25CM
• Type of Device: L-CATH PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• Manufacturer Contact: gina liu ; 1445 flat creek rd, athens, tx 75751
• MDR Report Key: 11455853
• MDR Text Key: 242909426
• Report Number: 1625425-2021-00862
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209910
• UDI-Public: 00886333209910
• Combination Product (y/n): N
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 28 GA (1.2F) X 25CM
• Device Catalogue Number: 384516
• Device Lot Number: 11308071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 03/10/2021 Patient Sequence Number: 1