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

Model Number 4440150

Device Problem Fracture (1260)

Patient Problems Swelling (2091); Palpitations (2467)

Event Date 01/03/2020

Event Type  Injury  

Manufacturer Narrative

Note: product reference (b)(4) is not cleared for sales in the usa, but its catheter is similar to the product reference (b)(4) cleared under #510k130576.Batch history review: we have checked the manufacturing file of batch nr 36948873 of celsite 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 (b)(6) 2019.Investigation results: we received for investigation a celsite access port nr 36948873 with two pieces of catheter and the connection ring.The proximal part of the catheter which was connected to the port measures 6,8 cm.The distal part measures 16 cm long.At the level of the rupture, the catheter present a partial clear cut.The facies is shiny; this is charateristic of a cut with a sharp object.Dimensional measurements: we have measured the returned catheter in order to check its conformity to our specification.The internal and external diameters conform to our requirements.Examination of the x-rays films: the x-ray pictures allow us to see that the rupture occured at the level of the neck, at the tunneling point, just before the catheter entry in the vessel.This suggests that the catheter was damaged during tunneling or suturing of the skin at this level.Conclusion: - the evaluation of the explanted device did not allow us to detect any manufacturing defect.- the catheter presents a clear cut donc by a sharp tool.- the rupture occured at the level of the neck, at the tunneling point.- a swelling was observed on the patient neck, the day 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 an accidental catheter damage done during the implantation procedure, probably while catheter tunneling or suturing of the skin at this level.The incident is not imputable to the device, no corrective action is envisaged.

Event Description

"the port was put on (b)(6) 2019 without complications.(b)(6) 2019 the chemotherapy was given for the first time - there was swelling on the neck, which resolved spontaneously the next day.The port was checked under x-ray with contrast - location and correct working.From (b)(6) 2019 to (b)(6) 2019 the patient's rehabilitation was carried out.(b)(6) 2019 at qualification to chemotherapy, there was no backflow of blood, and the patient reported a feeling of palpitations for several days.The port was not used - chemotherapy was given for peripheral injection.(b)(6) /2020 the patient reported for port control.No retrograde outflow, edema and pain in the port chamber were found when 0.9% was administered.Chest x-ray was performed, which showed detachment of the port catheter fragment.The echocardiography of the heart showed a fragment of the port catheter in the right ventricle.The patient was referred to the cardiology and interventional angiology clinic of the institute of cardiology in warsaw, where the catheter was removed from the heart chamber.Then on (b)(6) 2020 the chamber and the rest of the catheter were removed.During removal of the chamber, a fragment of the catheter was detached again, and the cannula ruptures were found in the place of its connection with the chamber.All port elements have been removed from the patient's body.".

• 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: 9700285
• MDR Text Key: 192409192
• Report Number: 9612452-2020-00005
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 04046964453618
• UDI-Public: 4046964453618
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 02/12/2020

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 Operator: Health Professional
• Device Model Number: 4440150
• Device Lot Number: 36948973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2019
• 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