MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-05 for THE GREENFILED RIGHT VENA CAVA FILTER 50-300 manufactured by Medi-tech, Boston Scientific Corporation.
[4170]
The 64 year old, male, in satisfactory condition underwent trans jugular placement of an inferior vena cava filter. After successful placement of the filter the 64 year old, male in satisfactory condition expired. Medical personnel became aware the device may or may not have been a direct cause of the event on 3/11/1993device labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: use of all similar devices stopped temporarily. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5655 |
| MDR Report Key | 5655 |
| Date Received | 1993-04-05 |
| Date of Report | 1993-03-15 |
| Date of Event | 1993-02-12 |
| Date Facility Aware | 1993-03-11 |
| Report Date | 1993-03-15 |
| Date Reported to Mfgr | 1993-03-11 |
| Date Added to Maude | 1993-07-20 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE GREENFILED RIGHT VENA CAVA FILTER |
| Generic Name | UNKNOWN |
| Product Code | DST |
| Date Received | 1993-04-05 |
| Model Number | 50-300 |
| Catalog Number | 50-300 |
| Lot Number | 63942 |
| ID Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Age | 01-FEB-93 |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 5354 |
| Manufacturer | MEDI-TECH, BOSTON SCIENTIFIC CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1993-04-05 |