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

Model Number 4436920

Device Problems Material Separation (1562); Migration (4003)

Patient Problem Implant Pain (4561)

Event Date 04/12/2022

Event Type  Injury  

Event Description

"with the introduction of a solution of sodium chloride 0.9 % into the port system, the patient complained of pain.When viewed in the area of the port system in the right subclavian region swelling.After ct examination revealed: separation of the port-system tube.Transfer to another hospital in the department of vascular surgery for catheter explantation.".

Manufacturer Narrative

Product reference 4436920 is not cleared for sales in the usa, but it is similar to the product reference 5430425 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 sold since may 2021.Investigation: despite our requests, either the device nor x-ray pictures were returned for analysis.A sample from our stock has been measured and tested.It complies with our specifications and requirements.Conclusion: without the device, it is not possible to conclude on the root cause of the catheter migration only 3 months after its implantation.This type of incident is a known and well documented potential adverse event of the implantation of access ports.The current complaint rate is low.No corrective action is envisaged.

Manufacturer Narrative

Note: product reference (b)(4) is not cleared for sales in the usa, but it is similar to the product reference 5430425 cleared under #510k130576.Batch history review: we have checked the manufacturing file of batch nr 36979069 which complies with our specifications and does not present any discrepancy.No other similar complaint was reported to us on this batch of access ports released in may 2021.Investigation results: we received for review two pictures of the explanted catheter: we can see two segments of catheter, probably the distal and the proximal part of the implanted catheter.These pieces of catheter are 5 to 7 cm long.One extermity of the catheter appears flattened.According to the additional information received: -"the device was implanted via subclavian venous access, for which the anesthesiologist performed a subclavian vein puncture using seldinger technique." -"upon admission to the next course of chemotherapy on april 12, 2022, the patient noted a tumor-like mass in the left shoulder joint, limitation of motion and pain in the left shoulder joint.Referred for a chest ct scan.Conclusion: status post implantation of access port system on the right.Violation of integrity of the access port system is detected, namely the tube is ruptured with the distal end identified in the lumen of the trunk and inferior branch of the left pulmonary artery." -" given the short period from catheter implantation to rupture (3 months), no chest x-ray control was performed." conclusion: - the catheter rupture occurred at 5 to 7 cm from the connection.- according to the received information, the catheter was implanted via subclavian vein and the catheter rupture occurred "in shoulder joint" after only 3 months these elements allow us to hypothesis that the catheter was crushed in the costo-clavicular space and repeated squeezing has led to the rupture of the catheter: it is the pinch-off syndrome.Only the examination of the catheter rupture facies and the review of the x-ray pictures could definitively allow us to confirm this hypothesis.The instructions for use warn the physicians against the risk entailed by placing via the subclavian route and give recommendations to avoid the risk of catheter rupture.It is a rare incident (0.01%).No corrective action is envisaged for the moment.

Event Description

"with the introduction of a solution of sodium chloride 0.9 % into the port system, the patient complained of pain.When viewed in the area of the port system in the right subclavian region swelling.After ct examination revealed: separation of the port-system tube.Transfer to anothr hospital in the department of vascular surgery for catheter explantation.".

• 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: 14801229
• MDR Text Key: 294948320
• Report Number: 9612452-2022-00028
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

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?: No
• Device Model Number: 4436920
• Device Lot Number: 36979069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Sex: Female