MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-05-21 for * 18 CM manufactured by Ekos Corp..
[7902182]
This incident was not reported directly to ekos by the user facility, so the investigation was based on the medwatch form completed by the user facility. Ekos investigated the returned catheter and downloaded the log file stored in the control unit at the user facility. The stored data for the device serial # reported was retrieved and examined. The log file data does not match the event description provided by the user facility. The log file indicates that following placement of the device in question, the instrument would not recognize the drug delivery catheter. The catheter was removed and replaced and the system worked correctly with the replacement catheter. Investigation of the catheter was limited to non-destructive testing at the direction of the user facility. The ultrasound core operated normally during testing. The drug delivery catheter was not recognized by the instrument due to a broken pin or wire, however, because the connector could not be disassembled, the exact cause could not be determined. Ekos does not consider this a reportable event. Eval: the log file in the control unit was available and was reviewed. Conclusion: the investigation results do not match the customer's report. No conclusion can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3001627457-2007-00004 |
| MDR Report Key | 975357 |
| Report Source | 06 |
| Date Received | 2007-05-21 |
| Date Mfgr Received | 2007-04-23 |
| Device Manufacturer Date | 2006-07-01 |
| Date Added to Maude | 2008-01-09 |
| 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 | 0 |
| Manufacturer Street | 11911 NORTH CREEK PKWY SOUTH |
| Manufacturer City | BOTHELL WA 98001 |
| Manufacturer Country | US |
| Manufacturer Postal | 98001 |
| Manufacturer Phone | 4254153132 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | CATHETER, CONTINUOUS FLUSH |
| Product Code | NUI |
| Date Received | 2007-05-21 |
| Model Number | 18 CM |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Expiration Date | 2008-07-31 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 943499 |
| Manufacturer | EKOS CORP. |
| Manufacturer Address | 11911 N CREEK PARKWAY SOUTH BOTHELL WA 98011 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-21 |