MAUDE Adverse Event Report: HOLOGIC, INC. CONTURA BALLOON; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Device Problems Leak/Splash (1354); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2016

Event Type  malfunction  

Event Description

Prior to insertion the balloon had a standard leak test by filling with saline and inspection for any visible leaks.None were seen at that time.The balloon was inserted and filled with 50cc's of saline (w/ contrast).This was on friday.We treated the patient the following monday, tuesday and the morning of wednesday (post insertion).We then performed a ct to reevaluate the balloon.After performing this ct (which we perform with all contura patients) we determined that the volume of the balloon had decreased by approximately 12cc.I contacted the company to find out what they suggest we do.They put me in contact with a consulting physicist.He talked me through a number of possibilities.He told me that we would want to contact the company after treatment if we determined that it was leaking/defective.We then replanned the plan for the smaller volume.This new plan was delivered for the afternoon of wednesday and the morning of thursday.For the afternoon treatment on thursday, we determined that more fluid had leaked based on the setup x-ray.An additional 10cc's were added to the balloon, after which we delivered the afternoon treatment (on thursday).The following morning of friday (7 days after insertion) we got a new ct scan.The balloon volume was 6cc less than the original plan (and therefore 6cc more than the ct on wednesday).The final two fractions were delivered on friday (7 days after insertion) and the balloon was removed.4 days later, on tuesday, i filled the balloon with 50cc and wrapped it in paper towels.I determined when i examined it the next day, wednesday that the balloon was leaking from the area of the vacuum port on the opposite side of the balloon from the lumens.We're now ready to contact the company and inform them that the device was leaking, and they will inevitably send us bags/packages to ship the defective device back to them.

• Brand Name: CONTURA BALLOON
• Type of Device: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 5932087
• MDR Text Key: 54057508
• Report Number: 5932087
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other