Product event summary: driveline cable (b)(4) was not returned for evaluation.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.Review of the controller log files could not be performed since log files covering the reported event date were not available for analysis.On-site inspection of the driveline cable revealed that the outer sheath was cracked, confirming the reported event.A driveline sheath repair was performed to mitigate the conditions reported.Based on the available information, the additional damage to the driveline was a progression of the previously reported damage.An internal investigation evaluated driveline sheath damages.Based on the investigation conducted, the most likely root cause of the driveline sheath damage is exposure to uv light.This event was assessed and is being reported as part of a retrospective review of events, which was in response to an update to the mdr decision criteria.This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.If information is provided in the future, a supplemental report will be issued.
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