MAUDE MDR 1612044

MDR report key
1612044
Report number
1612044
Event key
0
Event type
3
Date of event
2009-12-26
Date received
2010-01-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KOALANONECLINICAL INNOVATIONS LLC.HFN451739*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-01-2901. D

Event Narratives#

D

Patient 1

A (B) (6) GESTATION CAME FOR SPONTANEOUS LABOR AT 2:26 AM. LABOR PROGRESSED NORMALLY UNTIL 10:23 AM. AT 10:18 AM, AN INTRAUTERINE PRESSURE CATHETER (IUPC) WAS INSERTED. AT 10:23 AM THE FETUS EXPERIENCED A PROLONGED DECELERATION WITH FETAL HEART RATES (FHR) DROPPING TO THE 70'S. INTRAUTERINE RESUSCITATION EFFORTS WERE INITIATED. IN SPITE OF EFFORTS, THE FETUS CONTINUED TO DETERIORATE, A STAT C-SECTION WAS PERFORMED AND THE FETUS WAS BORN WITHOUT ANY SIGNS OF LIFE. ATTEMPTS TO RESUSCITATE THE BABY WERE UNSUCCESSFUL. THIS WAS AN UNUSUAL EVENT AND AN EXTENSIVE INVESTIGATION HAS BEEN CONDUCTED OVER THE PAST 30 DAYS. WE HAVE BEEN UNABLE TO DETERMINE THE CAUSE OF DEMISE FOR THIS BABY. IT WAS NOT ORIGINALLY THOUGHT TO BE RELATED TO THE IUPC AS THE IUPC WENT IN EASILY AND CLEAR FLUID WAS RETURNED. THE STAFF DID NOT SAVE THE IUPC BECAUSE THEY DID NOT BELIEVE IT HAD ANYTHING TO DO WITH THE DEMISE. WE HAVE NO EVIDENCE THAT IT WAS RELATED TO THE IUPC. WE ARE REPORTING BECAUSE THE TIMING OF INSERTION OF THE IUPC AND THE DETERIORATION OF FHR.