MAUDE Adverse Event Report: VYGON USA PREMICATH; LONG-TERM INTRAVASCULAR CATHETER

Model Number 1261.203G

Device Problems Device Dislodged or Dislocated (2923); Unintended Movement (3026)

Patient Problems Hematoma (1884); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

This malfunction was also sent to fda via medwatch report number 2402140000-2021-8007.The device will be returned to vygon for evaluation as part of the complaint investigation.The results of this investigation are still pending, and will be communicated to fda within 30 days of its conclusion via follow-up mdr.

Event Description

Picc line placed right sided access; noted large hematoma to right neck following start of infusion.The picc line was removed and upon removal there appeared to be a 100 piece of the guide wire lodged in through the picc line.The guide wire has since fallen out of the picc but both the picc and guide wire were retained for event review.

Manufacturer Narrative

We received one catheter as a sample.With the first attempt it was not flushable due to some obstructions.After placing the catheter in warm water, the catheter tube makes it possible to flush the catheter without detecting any leakage.A thorough step by step microscopic examination also did not show any defect which could have led to a leakage.Little fibrin could be detected inside the catheter's tip.Therefore, we could not comprehend the reason of complaint.A review of the batch history records was performed, and no deviations were found.Each catheter is flow and leak tested during production.The tensile force and dimensions of catheter components are randomly checked.Incoming goods inspections and two 100% visual tests after packaging are carried out.We have four additional complaints for the involved batches and one additional complaint regarding a leaking catheter on code 4g07126103 within the last three years.No further corrective action initiated by quality management as there are no indications of a manufacturing fault.Corrective action: based on the investigation, this issue could not be determined to be caused by manufacturing; therefore, no further corrective action will be initiated at this time.Both vygon usa and germany will continue to monitor this issue.

Event Description

Picc line placed right sided access; noted large hematoma to right neck following start of infusion.The picc line was removed and upon removal there appeared to be a 100 piece of the guide wire lodged in through the picc line.The guide wire has since fallen out of the picc but both the picc and guide wire were retained for event review.

• Brand Name: PREMICATH
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON USA; 2750 morris road; lansdale PA 19446
• Manufacturer (Section G): VYGON MFG; 87 venture drive; dover NH 03820
• Manufacturer Contact: freda o lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 12330664
• MDR Text Key: 266862957
• Report Number: 2245270-2021-00101
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1261.203G
• Device Lot Number: 20G023D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/13/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 08/13/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Life Threatening; Required Intervention; Other