FDA Adverse Event Injury Summary report: N

ARTIS Q BI-PLANE

MDR report key: 6731910 · Received July 21, 2017

Report

Report Number
6731910
Event Type
Injury
Date Received
July 21, 2017
Date of Event
July 7, 2017
Report Date
July 12, 2017
Manufacturer
SIEMENS HEALTHCARE GMBH
Product Code
OWB
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
WI, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE ROADMAP ON THE ANGIO SYSTEM WAS MALFUNCTIONING. THE LATERAL IMAGE WAS BOUNCING UP AND DOWN, CAUSING THE PROVIDERS TO NOT BE ABLE TO VISUALIZE THE WORK THEY WERE DOING. THE ANGIO SYSTEM WAS RESTARTED, AND THE PROBLEM WAS STILL OCCURRING. WE TRIED MULTIPLE TIMES TO RESET THE ROADMAP, WITH NO RESOLUTION. WE THEN TRIED USING A DIFFERENT ROADMAP, THE "ROADMAP WITH LOW NOISE WITHOUT CLEAR". UNDER THIS ROADMAP, THE PHYSICIAN NOTICED IMPROVEMENT WITH THE BOUNCING THAT WE HAD PREVIOUSLY SEEN. DUE TO THE IMAGE BEING IMPROVED, HE STARTED TO INJECT THE EMBOLIC AGENT (ONYX). WHILE INJECTING, HE WAS UNABLE TO SEE THE EMBOLIC ENTERING THE PATIENT. WE THEN TOOK THE MICRO-CATHETER OUT OF THE BODY, AND DID AN ANGIOGRAM WHICH DEMONSTRATED THAT THE EMBOLIC AGENT WAS INJECTED INTO AN UNINTENDED AREA. MANAGER INJURY REPORT: CONTACTED RISK MANAGEMENT. PAGED INTERVENTIONALIST TO GET MORE INFORMATION ON THIS ISSUE. HE SAID HE COULD NOT SEE THE ONYX WHEN INJECTING. HE SAID THAT THE IMAGING SUBTRACTED OUT THE ONYX WITH EVERYTHING ELSE. HE SAID THE REPRESENTATIVE FROM SIEMENS SAW THE INITIAL AREA AND SAID IT WAS A SOFTWARE BUFFER PROBLEM AND HAD TO DO A RESET. HE SAID THE REPRESENTATIVE FROM SIEMENS WAS PRESENT DURING THE BOUNCING ERROR EARLIER IN THE DAY. HE SAID THAT THE PATIENT IS A HEALTHY GUY WITH A BIG COIL MASS IN THE BRAIN AND THE INTERVENTIONALIST HAD IT MAGNIFIED, WHICH HE FELT MADE THE SIEMENS ISSUE WORSE. HE FELT THAT BECAUSE OF THE FOREIGN BODY THE SIEMEN'S SYSTEM HAD AN ISSUE SEEING IT. HE SAID IT TOOK TWO HOURS GETTING THE CATHETER IN PLACE. "AS I AM INJECTING, NOTHING IS CHANGING AND COULDN'T SEE ONYX WHERE NEEDED TO, SO I STOPPED." I ASKED HIM IF HE FELT THAT THERE WAS INJURY DUE TO THIS INJECTION AND HE SAID YES. THE PATIENT IS NOW HAVING SEIZURES AND VOMITING. HE SAID HE DOESN'T KNOW WHAT HIS NEXT STEPS WILL BE. SIEMENS REPRESENTATIVE IS ON VACATION SO LEFT HIM A VOICEMAIL TO CALL ME. MAKE/MODEL: ARIS Q BI-PLANE 10848282. SOFTWARE IS PURE SOFTWARE, BUT DON'T KNOW WHICH VERSION WE ARE RUNNING. SIEMENS IS REACHING OUT TO THEIR MAIN OFFICE FOR THE INFORMATION ON THIS. LEAD TECHNOLOGIST DID PUT IN A CALL TO INITIATE A TICKET TO HAVE SERVICE COME OUT TO CHECK OUT THE LAB. UPDATE: SEIMENS CAME TO THE FACILITY IN RESPONSE TO THE REPAIR TICKET THAT WAS PLACED. AFTER INSPECTING THE EQUIPMENT THEY DID FIND AND REPLACE A BAD POSITION SENSOR, WHICH IS NOT BELIEVED TO HAVE CAUSED THE ROADMAP BOUNCING. IN REGARD TO THE ROADMAP BOUNCING THEY WERE NOT ABLE TO FIND A SYSTEM ERROR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
512582 ARTIS Q BI-PLANE INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10848282

Patients

Seq Age Sex Outcome Treatment
1 23 YR Hospitalization