Catalog Number UNKNOWN G2 |
Device Problems
Detachment of Device or Device Component (2907); Material Deformation (2976)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Type
malfunction
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Manufacturer Narrative
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No device, no medical records, or no medical images were provided to the manufacturer.The lot number for the device was not provided; therefore, a review of the device history records could not be performed.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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Event Description
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It was reported that approximately eight years and ten months post deployment of a vena cava filter, a kub x-ray allegedly demonstrated one of the filter's limbs as fragmented or bent.The filter was reported as appropriately positioned.There was no reported patient injury.
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Manufacturer Narrative
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Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the device was not returned.Images and medical records were not provided.The investigation is inconclusive for filter limb detachment and material deformation.Based upon the available information the definitive root cause for this event is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: filter fractures are a known complication of vena cava filters.There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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Event Description
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It was reported that approximately eight years and ten months post deployment of a vena cava filter, a kub x-ray allegedly demonstrated one of the filter's limbs as fragmented or bent.The filter was reported as appropriately positioned.There was no reported patient injury.
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Search Alerts/Recalls
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