MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-04 for TITANIUM GREENFIELD VANA CAVA FILTER N/A 50-301 manufactured by Medi-tech.
[9911]
Patient underwent a vena cava filter insertion. The initial attempt resulted in premature deployment of the filter within the introducer sheath. This occurred without triggering the release mechanism for the filter. T he procedure was salvaged by withdrawing the introducer wheath and the contained filter to a point where the filter was out of the skin surface. At this point the sheath was transected with a knife blade and a guidewire was inserted through the remaining intravenous sheath and was successfully positioned within the vena cava. The procedure was then started over with the introduction of the sheath and subsequently a new vena cava filter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16276 |
| MDR Report Key | 16276 |
| Date Received | 1994-02-04 |
| Date of Report | 1993-11-10 |
| Date of Event | 1993-10-30 |
| Date Facility Aware | 1993-11-01 |
| Report Date | 1993-11-10 |
| Date Reported to Mfgr | 1993-11-10 |
| Date Added to Maude | 1994-09-21 |
| 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 | TITANIUM GREENFIELD VANA CAVA FILTER |
| Generic Name | VENA CAVA FILTER |
| Product Code | LWT |
| Date Received | 1994-02-04 |
| Model Number | N/A |
| Catalog Number | 50-301 |
| Lot Number | 114873 |
| ID Number | N/A |
| Device Expiration Date | 1996-04-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16209 |
| Manufacturer | MEDI-TECH |
| Manufacturer Address | 480 PLEASANT STREET WATERTOWN MA 02172 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-02-04 |