FDA.reportPublic FDA data

MAUDE MDR 2080610

MDR report key
2080610
Report number
3004672267-2011-00001
Event key
0
Event type
3
Date of event
2011-03-23
Date received
2011-04-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
BRYAN COWELL
Address
ONE TECHNOLOGY PARK DRIVE WESTFORD MA 01886 US
Phone
978-978-9786
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1C7 DRAGONFLY IMAGING CATHETERINTRAVASCULAR IMAGING CATHETERST. JUDE MEDICALNQQ13751-05NAUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-04-2201. H; 2. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A PT EXPERIENCED A STEMI THREE WEEKS PRIOR WITH SUBSEQUENT LEFT ANTERIOR DESCENDING (LAD) ARTERY STENT PLACEMENT. THE PT RETURNED AS AN OUTPATIENT FOR A PLANNED RIGHT CORONARY ARTERY (RCA) STENT PROCEDURE. THE PHYSICIAN REQUESTED OCT IMAGES OF THE LAD STENT DURING THE DIAGNOSTIC ANGIOGRAM. THE FIRST OCT IMAGING RUN WAS THE FIRST ANGIOGRAM TAKEN AND AFTER COMPLETING THE OCT IMAGING RUN, THE PT BECAME SEVERELY HYPOTENSIVE WITH BLOOD PRESSURE IN THE 30'S TO 40'S. RESUSCITATION INCLUDING FLUID BOLUS AND EMERGENCY DRUGS WERE INITIATED AND AFTER APPROX 30 MINS WITH NO CHARGE, AN INTRA AORTIC BALLOON PUMP (IABP) WAS INSERTED. A RIGHT HEART CATHETERIZATION REVEALED A WEDGE PRESSURE OF 5 AND THE PHYSICIAN DETERMINED DEHYDRATION OF THE PT MADE THE CONTRAST BOLUS INTOLERABLE. THE PT REQUIRED CONTINUATION OF IABP AND VASSOPRESSURE MEDICATION. THE PHYSICIAN ANTICIPATES THE PT WILL MAKE A FULL RECOVERY. THE PHYSICIAN STATED THAT THE USE OF THE OCT IMAGING DID NOT CAUSE THE EVENT AND THE EVENT WAS UNRELATED TO THE OCT DRAGONFLY CATHETER. INFO RECEIVED ON (B)(4) 2011 REPORTED THAT THE PT WAS RECOVERED AND THE EVENT WAS DEEMED A CONTRAST REACTION.

N

Patient 1

NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER, THE PHYSICIAN REPORTED THAT THE EVENT WAS CAUSED BY A POSSIBLE REACTION TO CONTRAST MEDIA. THE C7 DRAGONFLY CATHETER'S INSTRUCTIONS FOR USE STATES IN THE WARNING SECTION - REFER TO THE CONTRAST MEDIA'S INSTRUCTION-FOR-USE FOR GENERAL WARNINGS AND PRECAUTIONS RELATING TO USE OF THE CONTRAST MEDIA.