MAUDE Adverse Event Report: HOLOGIC, INC. MAMMOSITE; INSTRUMENT, MANUAL, SURGICAL

Catalog Number 9031

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 03/21/2014

Event Type  malfunction  

Event Description

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.

• Brand Name: MAMMOSITE
• Type of Device: INSTRUMENT, MANUAL, SURGICAL
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 3735270
• MDR Text Key: 18797931
• Report Number: 3735270
• Device Sequence Number: 1
• Product Code: JAQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 9031
• Device Lot Number: 13F17RC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR