MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-10-23 for BALLOON APPLICATOR KIT - 5-6 SPHERICAL AB2056 manufactured by Xoft, Inc..
[19461249]
A very slow leak (13cc over nearly 3 days) with a balloon applicator that was placed for brachytherapy in the breast. Balloon was extracted and a second balloon was placed. Treatment was completed successfully. Incident did not result in a pt injury. Balloon leak is an anticipated adverse event per the instructions for use.
Patient Sequence No: 1, Text Type: D, B5
[19710270]
Balloon leak during brachytherapy of the breast is an anticipated event. The leak was very slow (13cc over nearly 3 days). The balloon actually did not necessarily have to be replaced. It could have just been refilled and treatment resumed. The balloon in this event was evaluated including a review of the dhr, visual inspection and sem images. Investigation revealed leak was due to a manufacturing defect within the end hub portion of the balloon applicator. This is the first occurrence of this type of failure since commercial release of the device. Leaks are checked on every balloon applicator as part of the manufacturing process. The balloon was replaced and the treatment completed successfully. Pt was not harmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005594788-2009-00005 |
| MDR Report Key | 1527269 |
| Report Source | 05,06 |
| Date Received | 2009-10-23 |
| Date of Report | 2009-10-22 |
| Date of Event | 2009-09-28 |
| Date Mfgr Received | 2009-09-28 |
| Device Manufacturer Date | 2008-06-01 |
| Date Added to Maude | 2010-02-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVE LIN |
| Manufacturer Street | 345 POTRERO AVE. |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer Phone | 4084192341 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALLOON APPLICATOR KIT - 5-6 SPHERICAL |
| Generic Name | BALLOON APPLICATOR |
| Product Code | JAD |
| Date Received | 2009-10-23 |
| Returned To Mfg | 2009-10-15 |
| Catalog Number | AB2056 |
| Lot Number | 800041 |
| Device Expiration Date | 2010-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, INC. |
| Manufacturer Address | 345 POTERO AVE SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-10-23 |