MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-11 for LYSUS INFUSION CATHETER 060725062-004 500-52118 manufactured by Ekos Corporation.
[558295]
An ekos lysus infusion catheter was placed in the patient. Four hours later, the ultrasonic core had failed. The patient was returned to interventional radiology where the catheter was successfully removed and replaced with a new device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 839568 |
| MDR Report Key | 839568 |
| Date Received | 2007-04-11 |
| Date of Report | 2007-04-11 |
| Date of Event | 2007-03-08 |
| Report Date | 2007-04-11 |
| Date Reported to FDA | 2007-04-11 |
| Date Added to Maude | 2007-04-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LYSUS INFUSION CATHETER |
| Generic Name | CATHETER, IV |
| Product Code | NUI |
| Date Received | 2007-04-11 |
| Model Number | 060725062-004 |
| Catalog Number | 500-52118 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 826856 |
| Manufacturer | EKOS CORPORATION |
| Manufacturer Address | 22030 20TH AVE SE SUITE 101 BOTHELL WA 98021 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-11 |