MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2006-06-08 for KOALA INTRAUTERINE PRESSURE CATHETER KOALA IUPC IPC-5000E manufactured by Clinical Innovations.
[486939]
A first-time mom was in the l&d for induction. A koala catheter was placed by a first-year resident. Bright-red blood was seen in the lumen of the catheter; however, the catheter was advanced to the 45 cm mark without delay and left in place. Fetal heart tones dropped to the low 100's -- they previously had been reassuring. A bolus of fluid (undocumented amount) was then administered through the catheter in an attempt to alleviate suspected cord compression. The pt was rolled on her side and a large amount of blood was visualized in the bed. The catheter was removed and the fetal heart dropped to the 90's. A cesarean section was performed approximately 8 minutes after the catheter was placed. Evidence found at the time of the surgery showed a fresh abruption. They were not able to resuscitate the infant and the mother required 2 units of blood. The placenta was sent to pathology and they did not report a perforation or vasa previa, but a fresh abruption was noted.
Patient Sequence No: 1, Text Type: D, B5
[7844638]
The hosp did not report this event to us; however, our authorized dealer did learn of the event and immediately contacted our office. Our medical director contacted the hospital's clinical nurse specialist to get more information. Clinical nurse specialist informed medical director that she didn't think the koala catheter was at fault, but believed the resident who placed the catheter did not know how to use the device properly. Though we cannot tell if the koala catheter actually caused the placental abruption, misuse of the device can cause difficulties. One of the major benefits of the koala's clear lumen is that upon initial insertion, the clinician can quickly determine if the catheter has been placed outside of the amniotic space. According to our instructions for use and packaging, the clinician is to only insert the catheter about 8 cm, to the line that says "pause for flashback," and wait to see if amniotic fluid or blood returns down the catheter. If blood returns, the catheter is not to be inserted any further, but rather withdrawn and reinserted into another quadrant where a return of amniotic fluid can be obtained. Once amniotic fluid is seen, the catheter can be inserted completely. According to the clinical nurse specialist, this most basic caution was not taken. Also, our instructions for use clearly indicate that a user is never to infuse fluid through a catheter that is known, or even suspected, to be placed outside of the amniotic space. From speaking with the clinical nurse specialist , the rns knew of the features and benefits of the koala device, but the resident who placed it did not. We have offered follow up training and are sending additional training materials to the hospital to help avoid a similar problem in the future.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722684-2006-00004 |
| MDR Report Key | 724537 |
| Report Source | 08 |
| Date Received | 2006-06-08 |
| Date of Report | 2006-06-07 |
| Date Mfgr Received | 2006-06-05 |
| Date Added to Maude | 2006-06-12 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | WILLIAM WALLACE |
| Manufacturer Street | 747 W. 4170 SOUTH |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012688200 |
| Manufacturer G1 | CLINICAL INNOVATIONS |
| Manufacturer Street | 747 W. 4170 SOUTH |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84123 |
| 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 | 2006-06-08 |
| Model Number | KOALA IUPC |
| Catalog Number | IPC-5000E |
| Lot Number | UNK |
| Device Availability | N |
| Device Age | DAY |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 713463 |
| Manufacturer | CLINICAL INNOVATIONS |
| Manufacturer Address | 747 WEST 4170 SOUTH MURRAY UT 84123 US |
| Baseline Brand Name | KOALA INTRAUTERINE PRESSURE CATHETER |
| Baseline Generic Name | INTRAUTERINE PRESSURE CATHETER |
| Baseline Model No | KOALA IUPC |
| Baseline Catalog No | IPC-5000E |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Required No Informationntervention | 2006-06-08 |