MAUDE Adverse Event Report: B.BRAUN MEDICAL SAS CELSITE; ACCESS PORT SYSTEM

Model Number 4433742

Device Problems Entrapment of Device (1212); Fracture (1260)

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

Event Date 05/31/2021

Event Type  malfunction  

Manufacturer Narrative

Product reference (b)(4) is not cleared for sales in the usa, but its catheter is similar to the product reference (b)(4) cleared under #510k130576.Batch history review: we have checked the manufacturing file of the involved batch which complies with our specifications and does not present any discrepancy.No similar complaint has been reported to us on this batch of access ports released in (b)(6) 2015.Investigation results we did not received the complaint sample nor the x-ray pictures for investigation.Conclusion: according to the incident description, we can hypothesis that the catheter was incorporated in the vein when the physician attempted to remove it.This incorporation has led to its rupture while trying to remove it.This is a known complication of access port implantation, the ifu mentioned: "when removing the system, care must be taken not to fracture the catheter.[.]if the catheter is sutured into the vessel, the sutures should first be removed.Be vigilant if there is excessive resistance to the removal of the catheter.Catheters may become encapsulated and attached to the vein wall.Should this occur and it is not possible to remove the catheter without risking catheter fracture, or if the catheter is fractured, the advice of an interventional radiologist, surgeon or other physician with experience in endovascular treatment should be sought." this type of complication is more frequent on children because the catheter tip position changes as the child grows and this predisposes to this type of complications.The ifu specify : "following implantation of a port in a child particular attention should be given to the position of the catheter tip.Over time, as the child grows, the position of the catheter tip will change and move higher in the superior vena cava.As for any catheter, a high tip position in the svc predisposes the catheter to fibrin sheath formation and other mechanical difficulties.The position of the catheter tip should be checked radiographically a minimum of every 12 months or more frequently if the child is growing quickly.The system should be changed when the tip reaches the level of t4." this is a rare incident (0.02%), no corrective action is envisaged at the moment.

Event Description

Removal of an implantable access port, placed in a (b)(6) baby on (b)(6) 2016.Withdrawal at almost 5 years.Upon removal of the chamber, catheter rupture with minimal traction, therefore adherent and weakened catheter.According to the retrieved catheter which has marks every 5 centimeters, it is just under 4 centimeters missing.Need for additional extraction by endovascular route.No immediate risk of migration because the catheter is adherent to the vessel wall.Need for new general anesthesia and cardiovascular catheterization, in addition to moving the patient to another hospital (b)(6).

• Brand Name: CELSITE
• Type of Device: ACCESS PORT SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS; 26 rue armengaud; saint cloud, 92210 ; FR 92210
• Manufacturer (Section G): B.BRAUN MEDICAL SAS FRANCE; 30 avenue des temps modernes; chasseneuil du poitou, 86360 ; FR 86360
• Manufacturer Contact: catherine boismenu ; 30 avenue des temps modernes; chasseneuil du poitou, 86360 ; FR 86360
• MDR Report Key: 12141821
• MDR Text Key: 263863339
• Report Number: 9612452-2021-00030
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2021

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 Expiration Date: 12/31/2019
• Device Model Number: 4433742
• Device Lot Number: 36893712
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2015
• 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): Required Intervention
• Patient Age: 5 YR