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

Catalog Number	4433750
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/16/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Despite the manufacturer's requests, nor the device, the batch number or the x-ray pictures have not been forwarded for evaluation.Consequently, no thorough investigation can be performed.The complaint database does not show an increasing trend for this type of incident.It is a known complication of the access port system implantation and use.Consequently, no corrective action is envisaged.
Event or Problem Description
"broken catheter after 4.5 years.A child has an access port implanted next to the heart.The broken tube disappeared into the heart.".
Additional Manufacturer Narrative
Batch history review: the manufacturing file of this batch of access ports has been checked.It complies with the specifications and does not present any discrepancy.No other incident has been reported on this batch of (b)(4) access ports sold since february 2011.Investigation results: the involved celsite st305 access port from batch (b)(4) was returned for evaluation.The catheter is cut into 2 pieces: one 1.6cm long piece received inside the connection ring (proximal part) and a 10.7 cm long piece of catheter (distal part).The rupture facies (rough and irregular) of both pieces of catheter match together.A the level of the rupture, we can see traces of calcification.The device is dimensionally compliant with the specifications.No manufacturing defect is visible on it.X-ray pictures examination: (b)(6) 2011 = x-ray pictures taken the day of the implantation : the catheter is correctly positioned in a right jugular approach.(b)(6) 2015 = x-ray pictures taken the day of the device explantation : the distal part of the catheter has migrated into the heart.The access port housing is not visible.It has most probably already been removed.Conclusion: the catheter is broken at 1.6cm of the access port housing, the jugular approach was used, the rupture facies is rough and irregular, the examination of the x-ray pictures taken at the time of the implantation did not allow us to note any catheter mal-positioning.The elements received for investigation did not allow us to conclude on the origin of the catheter rupture.We can venture the hypothesis that the catheter was sutured at this level, which has weakened the catheter and lead to its rupture after more than 4 years of implantation.

• Brand Name: CELSITE
• Common Device Name: ACCESS PORT SYSTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS - OWNER; 204 avenue du marechal juin; boulogne billancourt, ile de france 92100 ; FR 92100
• MDR Report Key: 5401700
• Report Number: 9612452-2016-00003
• Device Sequence Number: 589163
• Product Code: LJT
• UDI-Device Identifier: 04046963594954
• UDI-Public: 04046963594954
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K130576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Followup
• Report Date (Section B): 03/04/2016

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: No Information
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 4433750
• Device Lot Number: K0312590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2016
• Supplement Report FDA Received Date: 03/07/2016
• 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
• Patient Age: 7 YR
• Patient Weight: 28