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

Model Number 4433842

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

Note : product reference 4433842 is not cleared for sales in the usa, but similar product reference 5433842 is cleared under #510k130576.Batch history review: we have checked the manufacturing file of batch 36928028 which complies with our specifications and does not present any discrepancy.No other incident has been reported to us on this batch of access ports released in august 2018.Investigation results: we received for investigation one celsite babyport s access port from batch 36928028 with its connection ring and a 4mm long piece of catheter connected on the exit cannula.The distal part of the catheter has not been returned for investigation.The catheter rupture occurred under the connection ring, at the level of the exit cannula's shoulder.This part of the catheter is protected by the connection ring during the implantation period.After having removed the catheter from the exit cannula, we can see some scratches on the exit cannula.This proves that a tool was used for the catheter mounting on the exit cannula during the implantation procedure.The observation of the rupture facies allows to see 2 marks of breaking initiation, probably done by a tool (e.G.Forceps/pliers).The catheter, the connection ring and the exit cannula were measured.All the measurement are compliant with the specifications.Conclusion: no manufacturing defect has been detected on the returned device.The catheter rupture occurred under the connection ring, shortly (7 months) after the implantation.According to the above mentioned information and in view of the location of the catheter rupture, we can hypothesis that the catheter rupture is due to the extension of a catheter damaged done during the implantation procedure, probably while mounting the catheter on the exit cannula.The ifu specifies: §vi "· during implantation ensure that the catheter is not damaged by unguarded forceps, suture needle or other sharp instruments." this is a rare incident, no directly imputable to the device.Consequently, no corrective action is envisaged.

Event Description

During a treatment, the nurse tests the catheter (normal protocol) and finds that there is no reflux.A chest x-ray is taken.Doctors notice a rupture of the catheter at the exit of the chamber, moreover it has migrated into the heart and wrapped itself in a ventricle.The child is immediately taken to interventional cardiology, the doctors have managed to recover the piece of catheter.Then the child is taken to the operating room for the removal of this implantable chamber to place another one in order to continue his treatment.

• 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: 8782533
• MDR Text Key: 150844919
• Report Number: 9612452-2019-00080
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2023
• Device Model Number: 4433842
• Device Lot Number: 36928028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Date Manufacturer Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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: 1 YR