Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged occlusion as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.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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It was reported through the results of a clinical trial, approximately one year post study conduit placement, the subject experienced thrombosis of vascular access.The study conduit was dissected and an embolectomy catheter was used to unblock the proximal and distal segments.Good inflow and outflow were achieved; therefore, the conduit was sutured and there were no signs of bleeding.The subject was discharged home approximately two days later.
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