GREENFIELD VENA CAVA FILTER SYSTEM JS-2846 50-100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-01 for GREENFIELD VENA CAVA FILTER SYSTEM JS-2846 50-100 manufactured by Medi-tech.

Event Text Entries

[19493815] Surgical procedure to place greenfield vena cava filter. As device was being inserted into the vena cava, the filter ejected prematurely and lodged in the vena cava. Attempts at removal were unsuccessful. In the process, the vena cava was knicked and blood loss occurred, necessitating a transfusion. The decision was made to leave the filter in and insert a second one at the site originally intended. This was accomplished. The patoient was observed post operatively and has had no problems. Device labeled for single use. Patient medical status prior to event: critical 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. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: inserviced by manufacturer/distributor representative. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3872
• MDR Report Key: 3872
• Date Received: 1992-07-01
• Date of Report: 1992-06-23
• Date of Event: 1992-06-11
• Date Facility Aware: 1992-06-11
• Report Date: 1992-06-23
• Date Reported to Mfgr: 1992-06-18
• Date Added to Maude: 1993-05-07
• 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

Device Details

• Brand Name: GREENFIELD VENA CAVA FILTER SYSTEM
• Generic Name: VENA CAVA FILTER
• Product Code: LWT
• Date Received: 1992-07-01
• Model Number: JS-2846
• Catalog Number: 50-100
• Lot Number: 47477
• Device Expiration Date: 1994-04-01
• Operator: OTHER
• Device Availability: Y
• Device Age: 01-MAY-91
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 3612
• Manufacturer: MEDI-TECH

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-01