MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-12 for BALLOON APPLICATOR KIT 3-4 SPHERICAL AB2034 manufactured by Xoft, Inc..
[2682378]
The customer reported that after performing a brachytherapy treatment on a pt using the xoft, 3-4 balloon applicator they noticed the balloon had deflated due to a small leak at the tip. No pt injury was reported. Balloon leak is an anticipated adverse event per the instructions for use.
Patient Sequence No: 1, Text Type: D, B5
[10065946]
Balloon leak is an anticipated adverse event per the instructions for use. The balloon in this event was evaluated including a review of the dhr, visual inspection and functional testing. The investigation results revealed a small leak at the two seroma holes located in the distal tip. Additional functional testing of the balloon assembly resulted in damage to the device. No further testing is possible. No actions are planned by the manufacturer at this time however, we will continue to monitor for the reported condition. No pt harm was reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005594788-2011-00030 |
| MDR Report Key | 2648666 |
| Report Source | 05,06 |
| Date Received | 2012-01-12 |
| Date of Report | 2012-01-10 |
| Date of Event | 2011-12-02 |
| Date Mfgr Received | 2011-12-12 |
| Date Added to Maude | 2012-08-06 |
| 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 NAUGLE |
| Manufacturer Street | 345 POTRERO AVE. |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal | 94085 |
| Manufacturer Phone | 6038825200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BALLOON APPLICATOR KIT 3-4 SPHERICAL |
| Generic Name | BALLOON APPLICATOR |
| Product Code | JAD |
| Date Received | 2012-01-12 |
| Returned To Mfg | 2011-12-14 |
| Catalog Number | AB2034 |
| Lot Number | 820586 |
| Device Expiration Date | 2013-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, INC. |
| Manufacturer Address | 345 POTRERO AVE SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-12 |