inforMED
DeathNQH

RADI PRESSUREWIRE 4

Received Mar 1, 2004 · Event occurred Feb 5, 2004

Report 514228 · MDR key 514228

Device

Generic name

0.014 Guidewire Mounted Pressure Sensor

Model number

*

Catalog number

*

Lot number

030784

Product problems

  • Explanted
  • Difficult to Remove

Patient

73 YR

  • Intimal Dissection
  • Death
  • Occlusion
  • Surgical procedure
  • Resuscitation
  • Blood pressure, low
  • Heart rate, decreased

Narrative

Description of Event or Problem

PT. UNDERGOING EMERGENT CARDIAC CATHETERIZATION. FINDINGS INCLUDED 40-50% STENOSIS OF LEFT MAIN CORONARY ARTERY (LMCA) AT ORIGIN AND 80% STENOSIS OF THE MIDPORTION OF THE CIRCUMFLEX ARTERY (CCX). AS CCX WAS FELT TO BE CAUSE OF SYMPTOMS, FFR MEASUREMENTS WERE TAKEN. INSTRUMENTATION AS LISTED BELOW. THERE WAS A SUBSTANTIAL GRADIENT ACROSS THE CCX LESION AND A DECISION MADE TO STENT THE LESION. ATTEMPTS TO PLACE THE STENT COULD NOT PASS BEYOND THE MIDPORTION OF THE LESION. ON ATTEMPTING TO PULL STENT BACK INTO THE GUIDING CATHETER, THERE WAS RESISTANCE. WITH SOME PULLING, THE STENT WAS PULLED ABOUT 20 CM. BACK INTO THE GUIDING CATHETER OVER THE RADI WIRE BUT COULD NOT BE RETRIEVED FURTHER. AFTER INSERTING A NEW BMW WIRE THROUGH THE GUIDING CATHETER ADJACENT TO THE RADI WIRE, AND ADVANCING IT PAST THE CCX LESION, THE RADI WIRE AND STENT WERE REMOVED AS A UNIT. JUST AFTER THIS, BLOOD PRESSURE DROPPED AND HEART RATE SLOWED. INJECTION TO LMCA REVEALED TOTAL LMCA OCCLUSION. FROM THIS POINT, PATIENT DETERIORATED, LMCA FLOW COULD NOT BE REESTABLISHED, AND RESUSCITATION FAILED AND THE PATIENT EXPIRED.