MAUDE Adverse Event Report: FLUOROSCOPE; SYSTEM, X-RAY, FLUOROSCOPIC IMAGE - INTENSIFIED

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 01/01/2010

Event Type  Injury  

Event Description

While stenting the mesenteric artery, the interventional radiologist had difficulty and did not move the fluoroscope for 45 minutes with magnification, unsure of times not documented.Due to this injury, he has had a rectus flap to remove dead tissue at the site, multiple stents 14 total, spontaneous rib fractures, and most recently cardiac bypass x 4.Suggestion: on consent for fluoroscope, it should state radiations is being given.For 2 reasons: make provider aware this does happen to pts - provider responsible; if general public knew this was a possible reaction, this pt may be identified sooner.I'm sure legal will not like it.Over radiated during a fluoroscopy procedure.

• Brand Name: FLUOROSCOPE
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC IMAGE - INTENSIFIED
• MDR Report Key: 6773573
• MDR Text Key: 82328827
• Report Number: MW5071438
• 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: Unknown
• Type of Report: Initial
• Report Date: 08/04/2017

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 55 YR
• Patient Weight: 90