MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-20 for ULTRAXX NEPHROSTOMY BALLOON UNB-6-15 manufactured by Cook Inc.
[184277743]
Device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[184277744]
It was reported, during a percutaneous nephrolithotomy (pcnl) procedure using a ultraxx nephrostomy balloon, when the physician pumped up the balloon to dilate, they found the balloon was not able to maintain the pressure they desired. The balloon was removed and they attempted to inflate it and discovered fluid flowing out through the tip of the catheter of the balloon. They kept pumping up the balloon to keep the pressure to finish the dilation. The patient's outcome was good. No adverse events have been reported as a result of the alleged malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00653 |
| MDR Report Key | 9859338 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2019-10-31 |
| Date Added to Maude | 2020-03-20 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRAXX NEPHROSTOMY BALLOON |
| Generic Name | LJE CATHETER, NEPHROSTOMY |
| Product Code | LJE |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-03-19 |
| Catalog Number | UNB-6-15 |
| Lot Number | 10119799 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |