MAUDE Adverse Event Report: XOFT, A SUBSIDIARY OF ICAD, INC. XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM; CONTROLLER

Model Number 110

Device Problems Output below Specifications (3004); Output Problem (3005); Radiation Underexposure (3018)

Patient Problems Breast Cancer (1759); Cancer (3262)

Event Date 02/12/2014

Event Type  malfunction  

Event Description

Patient was undergoing a bilateral iort brachytherapy procedure for breast cancer.During the radiation treatment of her breast, the main controller unit stopped delivering the radiation treatment.The patient received less than 95% of the prescriptive dose required.No serious injury was sustained by the patient.The treating physician indicated that the patient was scheduled for external beam radiation therapy to complete the procedure.Xoft internal tracking number: (b)(4).

Manufacturer Narrative

Device malfunction could not be replicated upon troubleshooting the controller unit at the customer site.It is believed that the unexpected shutdown of the unit was attributable to the old design of the high voltage cable.This component was replaced with the upgraded design.Unit was retested with no repeat occurrence of the initial malfunction.

• Brand Name: XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
• Type of Device: CONTROLLER
• Manufacturer (Section D): XOFT, A SUBSIDIARY OF ICAD, INC.; san jose CA
• Manufacturer Contact: al young ; 101 nicholson lane; san jose, CA 95134 ; 4084931541
• MDR Report Key: 3831973
• MDR Text Key: 4451389
• Report Number: 3005594788-2014-00001
• Device Sequence Number: 1
• Product Code: JAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 110
• Device Catalogue Number: XP1100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 77