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

Model Number 4440111

Device Problem Fracture (1260)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Note: product reference 4440111 is not cleared for sales in the usa, but it is similar to a product reference 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 other similar complaint has been reported on this batch of access ports released in june 2023.Investigation results: despite requests, we did not receive the complaint sample nor x-ray pictures for evaluation.Conclusion: without the complaint sample or x-ray pictures, we cannot conclude on the real cause of this incident.This is an isolated incident inside the whole batch, catheter rupture is a known complication of the access port implantation, documented in the ifu, this is a rare incident, no increasing trend is detectable in our complaint database, consequently, no corrective action is envisaged for the moment.

Event Description

Patient with catheter implanted since (b)(6) 2023 right subclavian without complications.Patient used per 4 months the device, until december 11, patient felt pain during chemo therapy infusion according to rx in thorax is confirmed total rupture of device below collarbone.Spacing no longer than 2 cm, patient sent to vascular surgery, retired fragment at right ventricle (endovascular procedure) on january 29th, catheter was retired with reservoir, detects fracture marks on 15 cm.

• 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: 19105581
• MDR Text Key: 340156653
• Report Number: 9612452-2024-00012
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2024

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 Model Number: 4440111
• Device Lot Number: 37011625
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2023
• 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): Other
• Patient Sex: Female