MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1991-12-24 for UNKNOWN manufactured by Meditech.
[18609932]
End portion of umbrella catheter seperated and lodged in right atrium during cath. Procedure. Patient felt no discomfort, but was transfered to other medical facility for emergency surgery to remove catheter tipdevice labeled for single use. Patient medical status prior to event: invalid data. 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. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device discarded. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 364 |
| MDR Report Key | 364 |
| Date Received | 1991-12-24 |
| Date of Report | 1991-12-04 |
| Date of Event | 1991-11-26 |
| Date Facility Aware | 1991-11-26 |
| Report Date | 1991-12-04 |
| Date Reported to FDA | 1991-12-04 |
| Date Reported to Mfgr | 1991-11-27 |
| Date Added to Maude | 1992-04-20 |
| 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 |
| Generic Name | VENA CAVA UMBRELLA FILTER |
| Product Code | LWT |
| Date Received | 1991-12-24 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 362 |
| Manufacturer | MEDITECH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1991-12-24 |