Catalog Number UNK DENALI |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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.
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Event Description
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It was reported that after an unknown period of time post deployment of a vena cava filter, a filter limb allegedly detached.There was no reported patient injury.No further information was provided.
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Manufacturer Narrative
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The device lot number was not provided; therefore, a manufacturing review was not performed.Visual inspection & functional/performance evaluation: the device was not returned; therefore, no visual inspection or functional testing of the device was performed.Medical records review: medical records were not provided for review.Image/photo review: images/photos were not provided for review.Conclusion: the device was not returned.Images and medical records were not provided.The investigation was inconclusive for the filter limb detachment.Based upon the available information, the definitive root cause was unknown.Labeling review: the current ifu (instructions for use) states: warnings: 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.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 after an unknown period of time post deployment of a vena cava filter, a filter limb allegedly detached.There was no reported patient injury.No further information was provided.
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Search Alerts/Recalls
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