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

Model Number 4436920

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2022

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.The investigation onto this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.

Event Description

"the patient was admitted for port removal.Part of the port was removed, but the second part (catheter) remained in the body.".

Manufacturer Narrative

Note: product reference (b)(4) is not cleared for sales in the usa, but it is similar to a product referenc ecleared under #510k130576.Batch history review: we have checked the manufacturing file of batch nr36982781 which complies with our specifications and does not present any discrepancy.No other similar complaint was reported to us on this batch of access ports released in april 2021.Investigation results: we did not receive the complaint sample for investigation.Conclusion: without the complaint sample or the x-ray pictures for investigation no thorough investigation is possible and we cannot conclude on the real cause of the incident.If new element become available in the future, we will re-open this complaint.Please note that the ifu specify :"when removing the system, care must be taken not to fracture the catheter.If the catheter is sutured into the vessel, the sutures should first be removed.Control the catheter while removing the system from the port pocket." this is a rare incident (b)(4) no corrective action is envisaged.

Event Description

"the patient was admitted for port removal.Part of the port was removed, but the second part (catheter) remained in the body.".

Manufacturer Narrative

Batch history review: we have checked the manufacturing file of batch nr36977974 which complies with our specifications and does not present any discrepancy.No other similar complaint was reported to us on this batch of access ports released in april 2021.Investigation results: we did not receive the complaint sample for investigation.Pictures review: we received 2 pictures for review.One picture is too dark to be conclusive.On the 2nd picture received, we can see a piece of catheter.It is too short to be the complete catheter implanted on the patient.It is contaminated by blood.The graduations are not visible on it.The catheter extremities facies are not visible on this picture.X-ray picture review: we received 1 x-ray picture.On this picture, we can see a piece of catheter located just after the subclavian pinch.This is the distal part of the catheter.The length seems to correspond to the catheter presents on the photograph.The access port housing and the proximal part of the catheter have probably already been removed as they are not visible on this image.Conclusion: the x-ray pictures show that the catheter rupture occurred in the subclavian area, this allows us to hypothesis that the catheter was crushed in the costo-clavicular space and repeated squeezing have led to catheter rupture: it is the pinch-off syndrome.However, only the examination of the explanted catheter could allow us to confirm this hypothesis.The instructions for use warn the physicians against the risk entailed by placing via the subclavian route and give advice to avoid pinch-off syndrome rupture.The incidnet is not imputable to the device.No corrective action is envisaged.

Event Description

"the patient was admitted for port removal.Part of the port was removed, but the second part (catheter) remained in the 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: 15215910
• MDR Text Key: 297763777
• Report Number: 9612452-2022-00037
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4436920
• Device Lot Number: 36977974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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: 55 YR
• Patient Sex: Female