MAUDE Adverse Event Report: FLUOROSCOPE

Device Problems Difficult to Insert (1316); Use of Device Problem (1670)

Patient Problems Nausea (1970); Vomiting (2144); Stenosis (2263); Complaint, Ill-Defined (2331); Injury (2348); Radiation Exposure, Unintended (3164); No Code Available (3191)

Event Date 01/07/2010

Event Type  Injury  

Event Description

To fda to whom it may concern: seven years ago my husband received a severe radiation injury during a stent placement.Since that time he has had a several procedures including a rectus flap when the necrotic tissue was removed from his right lateral abdominal wall.Gastrojejunostomy when the duodenum for malformed by the radiation exposure, continuing illness with frequent nausea/vomiting, intolerance to heat, spontaneous rib fractures, several stented arteries, until most recently open heart surgery x4 bypasses.The reason i am reaching out to you is an effort to ask how much more can be done to regulate the interventional radiologist and physicians doing these procedures.The interventional radiologist that performed this procedure on my husband.(b)(6), only documented that (b)(6) received 45 minutes of fluoroscopy time, no magnification was documented although i was told it did occur.Fluoroscopy is the highest dose of radiation that pts get during procedures.A lot of medical staff do not know this, or even that fluoroscopy is a radiation exposure procedure.This situation lead us to wonder what was happening to al for 11 months.None of the physician knew what it was.This makes identifying of injuries difficult.Just as a form of reference we coined the term for this "i.N.S.A.L.T.B" which is the acronym for "i've never seen anything like this before." fourteen doctors said this to us before a physicist in (b)(6)doing research on radiation injuries let us know that this "sounds like a hallmark radiation injury." there is a buzzer that sounds at the time the fluoroscopy needs to be moved or stopped, but this did not happen due to the interventional radiologist having difficulty placing the stent.Since this is a relatively small incidence of pts that receive these injuries.There should be secondary precautions in place to stop this altogether: assistance in the procedures should be able to say something to the provider if they identify the provider is taking too long without the scope without fear of retaliation; if the provider does get irritated with the assistant then after the fact this provider should be reprimanded; this also means that all assistance to these procedures need to be well educated in the radiation concerns; nowhere in the permission to have these procedures does it say that these pts are getting radiation; exposure to radiation should be part of the consent.During the research of this injury to my husband, i read everything in the medical record twice and sometimes three times.If there was a hint that he had been exposed to radiation maybe we could have gotten to that answer faster.After the first surgeries, when there was time to do the research on these injuries, it was my hypothesis that if these were discovered while the wounds are new or open, not waiting until the tissues have died, the hyperbaric chamber could stop some of this damage.But it is more difficult to identify these pt since they have the insalt b factor.This is not a well known injury or occurrence, luckily but if it happens to pts in the medical practice situation, it should be able to be stopped.I have been a nurse for 24 years and things change in medicine constantly, with new regulations at the time.This should not be that difficult.As a medical professional we should be willing to change with anything that will assist a pt in continued health.Thank you for your time.Respectfully, (b)(6).

• Brand Name: FLUOROSCOPE
• Type of Device: FLUOROSCOPE
• MDR Report Key: 6843472
• MDR Text Key: 85099308
• Report Number: MW5071963
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/31/2017

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Weight: 109