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

Model Number 4430433

Device Problems Break (1069); Unraveled Material (1664); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 10/28/2016

Event Type  Injury  

Manufacturer Narrative

Batch history review: no other complaint have been reported on this batch of guidewires sold since 2015.Investigation: the involved guidewire was sent to the manufacturer for evaluation.The other implantation accessories are not available.The j guidewire is completely unravelled and broken at its distal extremity.The welded tip is missing.Conclusion: the defects observed on the returned device seem to show that the guidewire remained blocked inside the 18g seldinger needle or inside the introducer dilator.Then the physician continued to pull on it to remove it.This blockage is generally due to the fact that the physician attempted to withdraw the guidewire through one of these accessories.The ifu's specify : "to prevent shearing of the guide-wire never withdraw the j guide-wire through the seldinger needle.Remove the guide-wire and the dilator together.Do not remove the guide-wire through the dilator as this may result in the guide-wire unravelling." this is a known risk of access port implantation.This incident is isolated.No corrective action is envisaged.

Event Description

"placement of a celsite st301f access port in a patient ((b)(6) years) with stomach cancer on (b)(6) 2016.The hydrophilic guide was broken during implantation procedure.A metal residue core remained inside the patient.".

• Brand Name: CELSITE
• Type of Device: ACCESS PORT SYTEM
• Manufacturer (Section D): B.BRAUN MEDICAL SAS - OWNER; 204 avenue du marechal juin; boulogne billancourt, 92100 ; FR 92100
• Manufacturer (Section G): B.BRAUN MEDICAL SAS - CHASSENEUIL; 30 avenue des temps modernes; chasseneuil, vienne 86361 ; FR 86361
• Manufacturer Contact: catherine boismenu ; 30 avenue des temps modernes; chasseneuil, 86361 ; FR 86361 ; 49627621
• MDR Report Key: 6144303
• MDR Text Key: 61437981
• Report Number: 9612452-2016-00048
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: EC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2016
• Device Model Number: 4430433
• Device Lot Number: 36901105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2015
• 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: 32 YR