Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.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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Same case as mdr id: 2134265-2017-02953.It was reported that an unknown guidewire fractured, the patent later experienced ventricular tachycardia and expired.The patient underwent an atherectomy procedure in (b)(6) 2011 to treat angina pectoris.Rotational atherectomy was performed with the use of a rotablator rotational atherectomy system, a rotawire, and an unknown ¿protect wire¿.During use, this unknown ¿protect wire¿ became detached.The patient was transported to another hospital in order to remove the detached wire fragment.Four days later, the patient experienced ventricular tachycardia and subsequently expired.
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