Model Number LSMU1350837 |
Device Problems
Occlusion Within Device (1423); Obstruction of Flow (2423)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the result of the investigation is inconclusive.The sample was not returned for evaluation.Based upon the available information a definitive root cause has not been determined.Labeling review: the instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.(expiry date: 08/2015); (manufacturing date: 09/2014).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 through the results of a clinical trial, that approximately three years post stent placement in the right common iliac artery, ultrasound demonstrated in stent stenosis.No reported intervention was performed.There was no reported patient injury.
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Manufacturer Narrative
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Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the result of the investigation is inconclusive.The sample was not returned for evaluation.Based upon the available information a definitive root cause has not been determined.Labeling review: the instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.(expiry date: 08/2015); (manufacturing date: 09/2014).
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Event Description
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It was reported through the results of a clinical trial, that approximately three years post stent placement in the right common iliac artery, ultrasound demonstrated instant stenosis.No reported intervention was performed.There was no reported patient injury.
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Search Alerts/Recalls
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