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

Model Number	5430425
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/31/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch history review: the manufacturing file was reviewed.It is compliant with our specifications and no abnormality was detected.No other similar complaint was reported on this batch of access ports.Investigation: despite several requests, either the involved device nor the x-ray pictures were returned for analysis.Conclusion: without the device for evaluation, no conclusion can be drawn concerning the cause of the catheter rupture.Catheter rupture is a known risk of access port implantation, indicated as a potential complication in the ifu.No corrective action is envisaged as this type of incident is rare.B braun (b)(4) has provided all the information currently available to us.In spite of all reasonable efforts being made to obtain further information or the device, at this time we have not met with success.
Event or Problem Description
Patient's family contacted b.Braun interventional systems to report the fragment of a port catheter severing and migrating to right atrium, which was successfully retrieved.Patient had port due to diagnosis of cancer.Shortly after discharge patient felt like something moved in her chest and began experiencing chest pains.Patient returned to implanting hospital and was told that pains were associated with port "settling in" and was sent home.Chest pains persisted, patient went to second hospital where they performed chest x-ray and determined a piece of the port catheter broke off and went into heart.Catheter segment was retrieved percutaneously through jugular vein.

• Brand Name: CELSITE
• Common Device Name: ACCESS PORT SYSTEM
• Manufacturer (Section D): B .BRAUN MEDICAL SAS; 204 avenue du marechal juin; boulogne billancourt, 92100 ; FR 92100
• MDR Report Key: 6197787
• Report Number: 9612452-2016-00050
• Device Sequence Number: 10809345
• Product Code: LJT
• UDI-Device Identifier: 04046963594817
• UDI-Public: 04046963594817
• Combination Product (Y/N): N
• PMA/510(K) Number: K130576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 12/21/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: 5430425
• Device Lot Number: K137685U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2016
• Initial Report FDA Received Date: 12/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention