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

Model Number 4433742

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/08/2022

Event Type  Injury  

Manufacturer Narrative

Note: product reference (b)(4) 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 batch nr 36983993 which complies with our specifications and does not present any discrepancy.No other similar complaint has been reported to us on this batch of access ports released in october 2021.Investigation results: we did not receive the complaint sample for investigation.Conclusion: the received elements do not allow us to conclude on the root cause of the catheter rupture detected during removal.If new elements become available in the future, we will reopen this complaint.This is a rare incident (<0.01%) and known complication of the access port implantation; no corrective action is envisaged for the moment.

Event Description

Catheter residue left in vessel.Catheter fracture.In cancer patients, during surgical removal of the port, the catheter adhered to the vessel wall, causing catheter breakage during removal of the catheter, leaving the end of the catheter in the vessel.There is a possibility that catheter fracture remains in the patient and embolizes.Catheter was adhered to vessel wall causing catheter breakage during catheter removal and catheter end left in vessel.Preliminary handling of event:timely identify and quickly remove the catheter to avoid leaving the catheter in the patient 's vessel.

• 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: 15543835
• MDR Text Key: 301361079
• Report Number: 9612452-2022-00046
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4433742
• Device Lot Number: 36983993
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• 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: 3 YR
• Patient Sex: Male