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..
[17512561]
The co talked with the midwife, on 10/01/97. She described the events as follows. The patient had delivered two previous babies without any problems, very quickly. She figured this one would go easily. Then she noted that patient started having "ugly" bradycardia and was concerned about the "crashing fhr". A physician suggested that she placed an iupc. She placed the koala. She had no training on the koala. She noted that the bradycardia occurred "long before" she placed the iupc. When she place the koala, she noted blood coming out the amnio lumen. They left in the iupc along with fse. They got "poor contractions" with late decels. She thought the tip wasn't as blunt as intran. C-section showed placenta in pieces. She thought abruption occurred before iupc was placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-1997-00002 |
| MDR Report Key | 126317 |
| Report Source | 05 |
| Date Received | 1997-10-14 |
| Date of Report | 1997-09-26 |
| Date of Event | 1997-09-14 |
| Date Mfgr Received | 1997-09-16 |
| Device Manufacturer Date | 1997-05-01 |
| Date Added to Maude | 1997-10-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOALA INTRAUTERINE PRESSURE CATHETER |
| Generic Name | INTRAUTERINE PRESSURE CATHETER |
| Product Code | HGS |
| Date Received | 1997-10-14 |
| Model Number | IPC-5000 |
| Catalog Number | IPC-5000 |
| Lot Number | 970104 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 123631 |
| Manufacturer | CLINICAL INNOVATIONS, INC. |
| Manufacturer Address | 6477 SOUTH COTTONWOOD STREET MURRAY UT 84107 US |
| Baseline Brand Name | KOALA INTRAUTERINE PRESSURE CATHETER |
| Baseline Generic Name | INTRAUTERINE PRESSURE CATHETER |
| Baseline Model No | IPC-5000 |
| Baseline Catalog No | IPC-5000 |
| Baseline ID | NA |
| Baseline Device Family | KOALA INTRAUTERINE PRESSURE CATHETERS |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K954955 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 1997-10-14 |