Manufacturer¿s investigation conclusion: the report of a severed pump cable was confirmed through the evaluation of the submitted images, as well as through an observation by an onsite abbott representative.An onsite driveline repair was performed on (b)(6) 2020 by abbott personnel.The driveline had been severed approximately 2 inches from the exit site.The distal portion of the driveline wires was replaced without issue; however, the strength member string was unable to be tied together due to its proximity to the exit site.No issues were noted post-repair.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The relevant sections of the device history records for the percutaneous lead were also reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped to the customer on 04nov2016.The heartmate 3 left ventricular assist system (hm3 lvas) instructions for use (ifu), rev.C, is currently available.Section 5 of this document cautions that sharp bends, twists, or kinks in the driveline may make it more susceptible to wear and fatigue over time.Section 6 of this document cautions the user to avoid pulling on or moving the driveline.This section emphasizes not to twist, kink, or sharply bend the driveline, system controller power cables, or mobile power unit patient cable, which may cause damage to the wires inside, even if the external damage is not visible.Damage to the driveline or cables could cause the pump to stop.If the driveline or cables become twisted, kinked, or bent, carefully unravel and straighten.Section 7 of this ifu also provides instruction regarding the driveline in a sub-section entitled "what not to do: driveline and cables".Section 8 of this ifu provides additional information regarding the driveline via ¿care of the driveline¿.The hm3 lvas patient handbook (rev.C) is also currently available.The patient handbook also provides information on proper care of the driveline.Section 8 of the patient handbook provides information regarding handling emergencies.The user should check the driveline daily for signs of damage (cuts, holes, tears) and call their hospital contact right away if the driveline is damaged (or might be damaged).No further information was provided.The manufacturer is closing the file on this event.
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