MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-10-30 for KOALA IPC 5000 IPC-5000E manufactured by Clinical Innovations.
[713243]
Upon insertion of an internal uterine pressure catheter (iupc), vaginal bleeding occurred subsequent emergent c-section required. It is suspected that the inserted device contributed to a placental abruption.
Patient Sequence No: 1, Text Type: D, B5
[8114134]
The following is the information obtained from the hospital: g2p1 at 39 weeks undergoing and induction of labor. The fhr was reassuring (120's with accelerations) prior to iupc placement. The iupc was placed and blood was visualized in the lumen of the catheter. No attempt was made to remove the catheter at that time. However, the fetal heart rate decreased within a minute a placement and failed to recover. The patient was delivered via an emergent cesarean section approximately 22 minutes after the iupc placement. The apgar scores were 0(1), 0(5), 0(10), & 2(15). The infant was resuscitated with fluid and blood in the or and transferred to the nicu. It was discharged after 4 days and according to the physician, the infant's eeg status is normal at 2 months. The placenta was examined by pathology and a "possible" puncture site was noted. It appears that the koala functioned appropriately. A flashback of blood was visualized, but apparently not heeded and the catheter was advanced completely into the patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722684-2007-00003 |
| MDR Report Key | 935586 |
| Report Source | 05 |
| Date Received | 2007-10-30 |
| Date of Report | 2007-10-29 |
| Date of Event | 2007-08-12 |
| Date Mfgr Received | 2007-09-12 |
| Device Manufacturer Date | 2007-05-14 |
| Date Added to Maude | 2007-11-05 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | WM. DEAN WALLACE |
| Manufacturer Street | 747 WEST 4170 SOUTH |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012688200 |
| Manufacturer G1 | CLINICAL INNOVATIONS, LLC |
| Manufacturer Street | 747 WEST 4170 SOUTH |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84123 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOALA IPC 5000 |
| Generic Name | IUPS INTRAUTERINE PRESSURE SYSTEM |
| Product Code | HGS |
| Date Received | 2007-10-30 |
| Model Number | IPC-5000E |
| Lot Number | 070448 |
| Device Expiration Date | 2009-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 908916 |
| Manufacturer | CLINICAL INNOVATIONS |
| Manufacturer Address | 747 WEST 4170 SOUTH MURRAY UT 84123 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-10-30 |