BIOSENSE WEBSTER, INC. (JUAREZ) PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
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Model Number D-1282-10-S |
Device Problem
Insufficient Information (3190)
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Patient Problem
Cardiac Perforation (2513)
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Event Date 02/02/2016 |
Event Type
Injury
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Manufacturer Narrative
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The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Concomitant product: carto 3 system, model #: m-4800-01, serial #: (b)(4).
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Event Description
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It was reported that a patient underwent an ablation procedure for ischemic ventricular tachycardia with a pentaray navigational eco catheter and suffered a cardiac perforation requiring surgical intervention.During the procedure, a cardiac perforation was confirmed via transthoracic echocardiogram.The patient was taken for surgical repair.There is no information about the hospitalization.The patient was reported to be in stable condition at the time the complaint was reported.The physician did not provide a causality opinion.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.Also during the procedure, there was a not reportable noise issue as the patient's heart rhythm was still visible to the operator.
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Search Alerts/Recalls
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