MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-31 for TITANIUM GREENFIELD VENA CAVA FILTER 50-300 manufactured by Medi Tech Boston Scientific Corporation.
[4199]
Patient was scheduled for a vena cava filter. On insertion filter failed to open and migrated to the pulmonary artery. It became necessary to place patient on bypass and perform median sternotomy to retreive filterdevice labeled for single use. Patient medical status prior to event: unknown. 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. Invalid data - regarding whether event presents imminent hazard. 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: mechanical problem, telemetry failure, other. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6390 |
| MDR Report Key | 6390 |
| Date Received | 1993-08-31 |
| Date of Report | 1993-07-23 |
| Date of Event | 1993-07-15 |
| Date Facility Aware | 1993-07-15 |
| Report Date | 1993-07-23 |
| Date Reported to FDA | 1993-07-23 |
| Date Added to Maude | 1993-09-02 |
| 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 | TITANIUM GREENFIELD VENA CAVA FILTER |
| Product Code | LWT |
| Date Received | 1993-08-31 |
| Catalog Number | 50-300 |
| Lot Number | 113853 |
| Device Expiration Date | 1996-04-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 6079 |
| Manufacturer | MEDI TECH BOSTON SCIENTIFIC CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-08-31 |