Same case as 2134265-2014-07525 and 2134265-2014-07280.It was reported that automatic pullback failure occurred.During an unspecified procedure, the motor drive unit (mdu) was used in conjunction with an unspecified imaging catheter and a sled.When performing pullback, the mdu did not perform automatic pullback.No patient complications was reported.
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Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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