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

Model Number 4430425

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Thrombosis (2100)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch history review: the manufacturing file was reviewed.It is compliant with our specifications and no abnormality was detected.No other similar complaint was reported on this batch of access ports sold since november 2017.Investigation: the device is still implanted into the patient's body.The x-ray pictures we received show a dislocation of the catheter tip from the right superior vena cava to the right jugular vein, 5 months after the access port implantation.However the information given by the patient are not sufficient to deduce the root cause of this catheter tip displacement.Conclusion: the information we have, is not sufficient to conclude on the exact root cause of the catheter tip dislocation.The catheter tip displacement is a known complication of the access port implantation, described in the literature.We advised the patient to meet his doctor for a follow up of his case.This is a very rare incident.No corrective action is currently envisaged.B braun sas has provided all the information currently available to us.

Event Description

The patient reported: "he catheter has kinked/looped above the venous insert point and is partly obstructing the venous flow due to its folding.Possibly due to the folded kink/loop, a fibrinous "stocking" has formed in the lower part of the kink/loop, and a thrombosis has formed in the upper part of the kink/loop.By inspection and measurement the thrombosis seems currently to have an approximate half diameter of that of the venous inside diameter".

• 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; 30 avenue des temps modernes; chasseneuil du poitou 86361 ; FR 86361
• Manufacturer Contact: catherine boismenu ; 30, avenue des temps modernes; chasseneuil du poitou, 86361 ; FR 86361
• MDR Report Key: 8500591
• MDR Text Key: 147325554
• Report Number: 9612452-2019-00064
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 04038653917341
• UDI-Public: 4038653917341
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/23/2022
• Device Model Number: 4430425
• Device Lot Number: 36925158
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other