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

Model Number 4440140

Device Problem Migration (4003)

Patient Problem Extravasation (1842)

Event Date 12/14/2023

Event Type  Injury  

Event Description

"58 year old patient with breast cancer who underwent central venous catheterization on (b)(6) 2023 at the (b)(6) clinic, which in the clinical history was well positioned, and on (b)(6) 2023, the patient's family reported that the chemotherapy cycle could not be started.In review of the patient with echo-doppler, a thorax x-ray is reviewed.Catheter is observed migrated towards the inferior vena cava and lateralized involved in the hepatic sulietta.Anatomically it may correspond to suprahepatic veins.Priority evaluation by vascular cx and interventional radiology is requested.".

Manufacturer Narrative

Note: product reference (b)(4) is not cleared for sales in the usa, but it 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 sold since (b)(6) 2023.Investigation: despite our requests, either the device nor x-ray pictures showing the incident were returned for analysis.Conclusion: without the device, it is not possible to conclude on the root cause of the catheter migration only 15 days 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 currently envisaged.

Event Description

"58 year old patient with breast cancer who underwent central venous catheterization on (b)(6) 2023 at the revivir clinic, which in the clinical history was well positioned, and on (b)(6) 2023, the patient's family reported that the chemotherapy cycle could not be started.In review of the patient with echo-doppler, a thorax x-ray is reviewed.Catheter is observed migrated towards the inferior vena cava and lateralized involved in the hepatic sulietta.Anatomically it may correspond to suprahepatic veins.Priority evaluation by vascular cx and interventional radiology is requested.".

Manufacturer Narrative

Note: product reference (b)(4) is not cleared for sales in the usa, but it is similar to the product reference (b)(4) cleared under #510k130576.Device history record: batch record number 37011835 was reviewed: it is within the specifications and no discrepancy was observed.No other similar complaint was reported on the (b)(4) units released in june 2023.Summary of investigation: - x-rays picture review: x-ray pictures taken on (b)(6) 2023, the day after the implantation: the device is implanted via the right subclavian vein.The catheter extremity is correctly positioned at the entrance of the heart.The correct connection of the catheter on the exit cannula is not verifiable on the received images.- visual inspection of the returned device: we received the access port housing and the connection ring.3 puncture marks are visible in the access port septum.No defect is visible on both elements.The catheter has not been returned for investigation.- dimensional measures: all the measured dimensions are compliant with the defined specifications.- pull test at the juncture access port-catheter the test was performed with a catheter from our stock from the same batch of tube.The performed pull test is compliant.The disconnection force applied on the catheter of the returned sample is more than 3 times superior to the iso 10555-6 standard requirements.- manufacturing step review: all the manufacturing steps that could lead to the observed defect were reviewed and no failure was detected.- raw material historical data review: the raw materials used for the batches of the catheter, connection rings and exit cannula included in the device kit were verified.They are compliant with the defined specifications.Another similar complaint was reported, which concludes to a disconnection due to an improper connection made by the medical staff.Root cause: the performed investigations have confirmed the compliance of the access port used by the end customer as no defect was detected.The short duration of the implantation (3 weeks) allows to hypothesis that the catheter might not have been completely mounted i.E., firmly push the catheter onto the exit cannula ensuring the catheter covers the exit cannula up to the stop.As required in the ifu.Recommendation to avoid disconnection of the catheter, the ifu specifies the following: - slide the connection ring over the catheter, firmly push the catheter onto the exit cannula ensuring the catheter covers the length of the exit cannula, slide the connection ring over the catheter and exit cannula.The connection ring should be in contact with the port (see fig.11c, page 115).· the catheter should be mounted on the exit cannula along its axis (see fig.11 a-b-c, page 115) and not across the axis and should be completely mounted on the exit cannula before the connection ring is slid over the catheter.Conclusion: this complaint is not confirmed as the performed investigations have confirmed the compliance of the device.The disconnection was probably due to an improper connection of the catheter with the access port housing, made by the medical staff.This is an isolated incident.No corrective actions is envisaged for the moment.

• 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: 18721783
• MDR Text Key: 336644247
• Report Number: 9612452-2024-00006
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

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 Model Number: 4440140
• Device Lot Number: 37011835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2023
• Is the Device Single Use?: No
• 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: 58 YR
• Patient Sex: Female