MAUDE Adverse Event Report: HOLOGIC, INC CONTURA; CATHETER

Catalog Number B012-45

Device Problem Burst Container or Vessel (1074)

Patient Problem No Information (3190)

Event Date 06/16/2014

Event Type  malfunction  

Event Description

Patient had contura partial radiation catheter placed.Prior to placement the surgeon checked the balloon.After placement patient had ct scan at outpatient treatment center to ensure placement and balloon patency; which was good.Three days later the patient returned to outpatient treatment center for treatment and the balloon had popped.Radiation treatment could not be completed and the catheter was removed.Patient was offered to have another catheter placed but patient declined.

• Brand Name: CONTURA
• Type of Device: CATHETER
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• MDR Report Key: 3918240
• MDR Text Key: 4514144
• Report Number: 3918240
• 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: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: B012-45
• Device Lot Number: REXJ0575
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2014
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 58 YR
• Patient Weight: 77