Manufacturer's investigation conclusion: evaluation of the returned coring knife confirmed the reported event of the knife not being sufficiently sharp.The coring knife was returned in a plastic bag.The coring knife was in used condition as residue consistent with blood was present on its internal and external body, as well as the blade edge.Microscopic inspection revealed that the blade edge had multiple imperfections.These imperfections consisted of folds/chips to the blade edge which appeared to have the potential to contribute to a cutting issue.A cut test was performed with the returned coring knife and a silicone sheet.The knife was unable to cut through the silicone sheet as expected, consistent with the reported event.It should be noted that a control coring knife was able to cut through the same silicone sheet without issue.An internal investigation by abbott has determined that the issue with the coring knife cutting edge was the result of a manufacturing issue traced to the coring knife supplier.Review of manufacturing documentation confirmed that the coring knife was part of the affected batches identified during this internal investigation.A corrective action was opened with the coring knife supplier to prevent recurrence of this issue.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.However, review of the batch history did confirm that the coring knife was part of the lots bracketed by manufacturing analysis task.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1, "introduction", lists the apical coring knife as an optional component for device implantation.Section 5, ¿surgical procedures¿, provides information on preparing and handling the coring knife.This section also states that during the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in an emergency.The device is included in the apical coring knife unable to cut advisory issued by abbott on 21aug 2023.No further information was provided.The manufacturer is closing the file on this event.
|