KOALA INTRAUTERINE PRESSURE CATHETER IPC-5000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-10-14 for KOALA INTRAUTERINE PRESSURE CATHETER IPC-5000 manufactured by Clinical Innovations, Inc..

Event Text Entries

[90202] After multiple contacts, the co finally talked to the physician who told co the following: this patient was on her 7th pregnancy, gestational diabetic, started cervical dilation 7-3 cm, who she wanted to give pitocin. She placed koala away from placenta and did not notice fluid or blood in amnio-lumen. After a couple of hours, she noted 5-6 cm dilation and some blood from vagina. She removed koala, not noting blood on it and did a crash c-section due to fhr of 60 and bleeding. At c-section the cavity was full of blood and noted a major abruption. The doctor's first impression was that the problem of timultuous contractions were due to an anterior fibroid and nothing to do with the koala which was placed posterior. When the nurses mentioned an earlier abruption the same day and that maybe the koala was involved. She considered it possible. But her impression of koala was that the tip was bigger than intran (which it isn't) and that could have caused the problem. She could not really say that the abruption had anything to do with koala. The co contacted the nurse director as well as other nurses on 10/1/97. She told me she did not contact the co directly, but spoke to a kol-bio medical rep. Who sells koala. She said that he came in the next day, 9/17/97, and she could see that the problems with both incidences were probably not caused by koala. She said that none of the midwives or physicians have been trained and she wants further training. The co has talked to the nurse manager on 9/16/97 and was told the same thing that time that the report was premature. As noted, the doctor told me that these only thought the koala might have been invovled after the nurses told her that they thought that they had a problem earlier that day with koals causing abruption (which it didn't). She still isn't sure koala had anything to do with the abruption. The co's conclusion is that the koala did not contribute to nor cause the adverse event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1722684-1997-00001
MDR Report Key126324
Report Source05
Date Received1997-10-14
Date of Report1997-09-26
Date of Event1997-09-14
Date Mfgr Received1997-09-16
Device Manufacturer Date1997-05-01
Date Added to Maude1997-10-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKOALA INTRAUTERINE PRESSURE CATHETER
Generic NameINTRAUTERINE PRESSURE CATHETER
Product CodeHGS
Date Received1997-10-14
Model NumberIPC-5000
Catalog NumberIPC-5000
Lot Number970104
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key123636
ManufacturerCLINICAL INNOVATIONS, INC.
Manufacturer Address6477 SOUTH COTTONWOOD STREET MURRAY UT 84107 US
Baseline Brand NameKOALA INTRAUTERINE PRESSURE CATHETER
Baseline Generic NameINTRAUTERINE PRESSURE CATHETER
Baseline Model NoIPC-5000
Baseline Catalog NoIPC-5000
Baseline IDNA
Baseline Device FamilyKOALA INTRAUTERINE PRESSURE CATHETERS
Baseline Shelf Life ContainedN
Baseline Shelf Life [Months]24
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK954955
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention 1997-10-14

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