CONTURA MLB *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-10-31 for CONTURA MLB * manufactured by Senorx, Inc..

Event Text Entries

[962859] The patient had a left axillary sentinel node biopsy and left wire-localized partial mastectomy with complex closure greater than 3mm. Before the cavity was closed, the mammosite cavity evaluation device was placed into the cavity, instilled with 35ml of saline and us was performed. The ultrasound demonstrated a balloon to skin thickness medial to the incision of 65mm, inferolateral to the incision 50mm and superolateral to the incision 75mm. The balloon was deflated and removed. Subsequently, approximately three weeks post-mastectomy, the patient had placement of a contura brachytherapy balloon in the left breast at the 2 - o'clock position with no complications. A simulation note, four days later, states that the balloon had been filled with 30ml of saline and 1ml of contrast to help with imaging. 3mm axial slices were taken of the breast. The images were sent to the treatment planning system and evaluated. It was apparent that the seroma in the superior position of the breast superior to the contura balloon remained intact with very little resolution. Evaluation of the lumpectomy cavity was that it was too far distant from the surface of the contura balloon due to the seroma. It was determined that she was not a candidate for partial breast radiation using that balloon. The balloon was pulled 5 days after initial placement, and the fluid extracted from the balloon was bloody and cloudy. The catheter was found to not be appropriate for the intended therapy and therefore was discontinued. The fluid in the balloon was found to be bloody and cloudy. Documentation indicates that 1 ml of contrast had been added to the 30 ml of saline which accounts for the cloudiness but not the bloody appearance.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1232665
MDR Report Key1232665
Date Received2008-10-31
Date of Report2008-10-31
Date of Event2008-10-14
Report Date2008-10-31
Date Reported to FDA2008-10-31
Date Added to Maude2008-11-18
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCONTURA MLB
Generic NameCATHETER, BRACHYTHERAPY, BREAST
Product CodeIWJ
Date Received2008-10-31
Model Number*
Catalog Number*
Lot NumberM08091606
ID Number*
Device AvailabilityN
Device Age1 DY
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key1283867
ManufacturerSENORX, INC.
Manufacturer Address11 COLUMBIA, SUITE A ALISO VIEJO CA 92656 US


Patients

Patient NumberTreatmentOutcomeDate
10 2008-10-31

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