Device Problems
Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Patient Problem
No Consequences Or Impact To Patient (2199)
Event Type
Malfunction
Manufacturer Narrative
As the lot number for the device was not provided, a lot history review could not be performed.
The device was not returned, however medical records were provided for review.
The investigation is confirmed for perforation and migration.
Based upon the available information, the definitive root cause for this event is unknown.
The devices are labeled for single use.
Event Description
This report summarizes one malfunction.
A review of the reported information indicated that an unknown vena cava filter allegedly experienced migration and perforation.
The information was received from a single source.
One patient was involved with no reported patient injury.
The reported patient is a (b)(6) year old female and her weight was not provided.