MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-03 for MAMMOSITE * 9031 manufactured by Hologic, Inc..
[18797931]
Cavity evaluation device ruptured after intraoperative placement by surgeon. During the surgical procedure, the surgeon tested the integrity of the balloon component of the cavity evaluation device by instilling 60 cc fluid with no issues. The fluid was removed, the device was placed and 45 cc fluid was instilled. The surgeon proceeded to evaluate placement via ultrasound exam, and was unable to visualize the balloon. The surgeon attempted to withdraw fluid from the balloon and at that time found that the balloon had ruptured. The device was removed. A second device was re-evaluated the same way, placed, and upon ultrasound exam, found to be intact and in the proper position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3735270 |
| MDR Report Key | 3735270 |
| Date Received | 2014-04-03 |
| Date of Report | 2014-04-03 |
| Date of Event | 2014-03-21 |
| Report Date | 2014-04-03 |
| Date Reported to FDA | 2014-04-03 |
| Date Reported to Mfgr | 2014-04-09 |
| Date Added to Maude | 2014-04-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAMMOSITE |
| Generic Name | INSTRUMENT, MANUAL, SURGICAL |
| Product Code | JAQ |
| Date Received | 2014-04-03 |
| Model Number | * |
| Catalog Number | 9031 |
| Lot Number | 13F17RC |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-03 |