Edwards received notification of a pascal in mitral position where the edwards team and the ic decided to bail out the ace device.When bailing out the ace, the ic had a difficult time elongating device all the way and the paddle knob bottomed out to the point where the physician could not counter clock/elongate device any further.The actuation wire was not seen to be detached on echo or fluoro.When device was safely removed from patient, it was noticed that the actuation wire was no longer attached.There was no harm caused to the patient.Additional information from a call with the site physician confirmed the sequence of events and suggested that the inability to elongate device may have potentially led to the actuation wire break.This information led to additional testing in product evaluation that was able to confirm the device malfunction of inability to elongate implant could lead to actuation wire break.
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Another code applicable to investigation findings is: malfunction observed without conclusive finding.The complaint for actuation wire breaks during repositioning and unable to elongate implant to reposition was confirmed with objective evidence of the returned device.No manufacturing non-conformities were found in the returned sample, no manufacturing non-conformances were found and no labeling, training, or ifu deficiencies were identified.Available information was unable to determine the severity of damage on the implant catheter prior to bailout.During bail out in a clinical procedure, the implant system with the implant attached is pulled into the guide sheath soft tip and then out of the guide sheath proximal seal may undergo high tensile load, which the implant catheter may be subjected to high tensile load.The physician was noted to be shaking of how much force was required to retrieve the system into the guide sheath.Additionally, the device was able to complete device preparation and device insertion without any issues noted.The cause of the unable to elongate implant to reposition could not be conclusively determined.As a result of implant catheter damage the affected device was unable to fully elongate leading to excessive force required during bailout potentially resulting in an actuation wire break.
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