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

Model Number XP1100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

No device malfunction was reported for this incident.This report is filed on the basis of the physician claiming a possible side affect to the patient attributed to the iort procedure.A service record review found no system anomalies related to the patient's reported incident.

Event Description

Patient underwent intraoperative brachytherapy (iort) treatment for breast cancer on (b)(6) 2018.The following day, she was admitted to (b)(6) (on (b)(6) 2018) for mild congestive heart failure with interstitial edema and trace bilateral effusions.She was released to home with oxygen life support.On follow-up with her primary care physician (pcp) on (b)(6) 2018, the physician indicated that the patient may have been fluid overloaded at the time of surgery, had an idiosyncratic reaction to the anesthetic, or an unreported side effect of the iort procedure.The physician changed the patient's blood pressure medications and the patient's symptoms were resolved.There was no reported malfunction for the brachytherapy system delivering the radiation treatment.(b)(4).

• Brand Name: AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
• Type of Device: BRACHYTHERAPY ELECTRONIC CONTROLLER
• Manufacturer (Section D): XOFT, A SUBSIDIARY OF ICAD, INC.; 101 nicholson lane; san jose CA 95134
• Manufacturer Contact: al young ; 101 nicholson lane; san jose, CA 95134 ; 4084931541
• MDR Report Key: 7653689
• MDR Text Key: 112841571
• Report Number: 3005594788-2018-00001
• Device Sequence Number: 0
• Product Code: JAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XP1100
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Hospitalization
• Patient Age: 87 YR