MAUDE Adverse Event Report: FLUOROSCOPE

Device Problem Radiation Overexposure (3017)

Patient Problem No Code Available (3191)

Event Date 09/01/2016

Event Type  Injury  

Event Description

Pt received 168.3 minutes of fluoroscopy (radiation exposure) associated with attempted prostate embolization as part of "prostate embolization for massive benign prostatic hypertrophy (bph)" research, ide number (b)(4), (b)(6) md sponsor/investigator.On (b)(6) 2016, (b)(6) was enrolled in the trial.He underwent pelvic angiography and received 168.3 minutes of fluoroscopy.Extended fluoroscopy report was filed with medical physics.The pt was notified and was given out form for extended fluoroscopy time.He will be evaluated at f/u visits for any skin changes and was also instructed to call if he notices and redness along his lower back.Spoke to the subject on (b)(6) 2016 and no adverse effects from exposure reported at this time.The device being tested in this ide is embosphere microspheres.This pt did not receive any embosphere microspheres.

• Brand Name: FLUOROSCOPE
• Type of Device: FLUOROSCOPE
• MDR Report Key: 5962961
• MDR Text Key: 55422650
• Report Number: MW5064853
• Device Sequence Number: 1
• Product Code: JAA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 81