MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-08-13 for COOK CHORIONIC VILLUS SAMPLING SET J-CVS-572700 manufactured by Cook Urological, Inc..
[2803687]
After applying the syringe and producing negative pressure, ultrasound imaging demonstrated a catheter within the substance of the placenta. There was noted to be no movement of material within the catheter despite clear visualization of the tip and middle of the catheter (not against uterine sidewall). The catheter was then moved and the retraction no material was seen. The syringe was withdrawn and suction did not break. The negative pressure was continued on the syringe and the catheter was removed from the vagina and visualized. At that time, there was a collapsed area of the catheter. The catheter was detached from the syringe and at this time, suction was broken. The syringe contents were placed into media and then the catheter was flushed with media to attempt removal of any villi. A large amount of blood and tissue (decidual) was noted to be floating in the media. The catheter had a small area that was still palpably collapsed, but at this time was able to be flushed. The pt did miscarry her pregnancy.
Patient Sequence No: 1, Text Type: D, B5
[10126277]
The customer received one used catheter that was attached to a terumo syringe. There was red liquid inside the catheter. A kinked area was noted in the catheter 1 cm above the hub. Using the returned syringe, water was injected into and aspirated from the catheter without difficulty noted. The catheters are shipped with the stainless steel stylet in place. Our directions for use instruct the customer to insert the catheter with the stylet in place and to slowly remove the stylet after catheter placement. Clinical specialists agreed that we do not have enough info on where the end of the catheter was located prior to aspiration and that too much vacuum pressure being placed from the syringe could have caused the catheter to collapse. If the physician was not diligent with their placements, damage to the fetus could easily be caused. The pt would have been a high risk pregnancy pt and at a higher risk for miscarriage, which is described in our pt info and instructions for use. Most likely, the difficulty the customer has experienced was iatrogenic in nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2012-00016 |
| MDR Report Key | 2706057 |
| Report Source | 05 |
| Date Received | 2012-08-13 |
| Date of Report | 2012-08-09 |
| Date Facility Aware | 2012-07-12 |
| Report Date | 2012-08-09 |
| Date Mfgr Received | 2012-07-12 |
| Date Added to Maude | 2012-08-28 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRIS KILANDER |
| Manufacturer Street | 1100 W. MORGAN |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK CHORIONIC VILLUS SAMPLING SET |
| Generic Name | LLX CATHETER, SAMPLING, CHORIONIC VILLUS |
| Product Code | LLX |
| Date Received | 2012-08-13 |
| Returned To Mfg | 2012-07-12 |
| Catalog Number | J-CVS-572700 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK UROLOGICAL, INC. |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2012-08-13 |