MAUDE Adverse Event Report: HOLOGIC, INC. HOLOGIC CONTURA 4.5CM MULTILUMEN BALLOON; CONTURA 4-5CM MULTILUMEN BALLOON

Model Number B11345

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Radiation Underdose (2166)

Event Date 01/30/2017

Event Type  Injury  

Event Description

A hologic contura balloon applicator for hdr breast brachytherapy was found to have questionable channel problems after it was inserted into a pt.The 5 channel applicator was discovered to have the inherent radiopaque marker on channel 4 rather than being on channel 1.This resulted in an inconsistency between the identification of the channels on the brachytherapy treatment plan and the mfr's labeling on the applicator.The plan was delivered to the pt for one of 10 planned fractions before this was identified.The applicator was then removed from the pt by the attending physician.Only one treatment was delivered.Visual inspection of the applicator confirmed the marker was on channel 4.The result is that the delivered radiation dose to the pt was rotated from planned dose distribution by 90 degrees.The plan was recalculated to match how it was treated.The actual dose to the pt differed from the planned dose by less than 20% for the target volume and all organs.

• Brand Name: HOLOGIC CONTURA 4.5CM MULTILUMEN BALLOON
• Type of Device: CONTURA 4-5CM MULTILUMEN BALLOON
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 6349266
• MDR Text Key: 68127031
• Report Number: MW5068016
• Device Sequence Number: 1
• Product Code: JAQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2018
• Device Model Number: B11345
• Device Lot Number: REHT1037
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 63