MAUDE Adverse Event Report: TELEFLEX MEDICAL VASONOVA VPS G4 CONSOLE/ACCESSORIES; CATHETER ULTRASOUND VASCULAR

Catalog Number VPS-G4C

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Picc line placement for long term home antibiotics.Picc line placed with no complications.Sustained blue bulls eye noted on vps machine with arm being dropped to side of body.Patient was discharged home with picc.Patient re-admitted on 1/10, admission x-ray showed picc line in the mid svc.Confirmation x-ray was shot on 1/12 to verify picc tip placement.As per x-ray report, picc does not demonstrate normal inferior downward projection, may be terminating closer to the svc brachiocephalic junction.

• Brand Name: VASONOVA VPS G4 CONSOLE/ACCESSORIES
• Type of Device: CATHETER ULTRASOUND VASCULAR
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18693692
• MDR Text Key: 335339411
• Report Number: 3003898360-2024-00177
• Device Sequence Number: 1
• Product Code: OBJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VPS-G4C
• Device Lot Number: 73K2100440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2021
• 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
• Treatment: NOT REPORTED