No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) for the lot number 17511629l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.Concomitant products: carto 3 system, model #: m-4800-01, serial #: (b)(4); smartablate generator, model #: m-4900-07, serial #: (b)(4); smartablate pump, model #: m-4900-08, serial #: (b)(4); smarttouch bidirectional catheter, model #: d-1327-05-s, lot #: 17525651m; soundstar eco catheter, model #: m-5723-15, lot #: unknown.Manufacturer's ref.No: (b)(4).
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It was reported that a (b)(6) male patient underwent an ablation procedure for atrial fibrillation with a pentaray navigational eco catheter and suffered a medical device entrapment.During the procedure, the pentaray catheter was inadvertently passed through the prosthetic mitral valve.There was resistance/difficulty during removal of the catheter since the spine was stuck in the prosthetic mitral valve.Upon attempting to remove the catheter, the last 2 electrodes and the dome tip of one of the spines became lodged in the valve and detached from the catheter.It was noted that the spine detachment did result in wires and/or braid being exposed.Damage did not result in any lifted or sharp edges.Remainder of the procedure was aborted.The patient was reported to be in stable condition.There is no information regarding extended hospitalization.The detached spine tip re-located from the mitral valve to an unspecified location in a lower extremity.The physician to follow up with interventional radiology to discuss treatment options.There is no information regarding the treatment decision or the patient outcome.The physician's opinion regarding the cause of the adverse event is that it was procedure-related and patient-related (prosthetic mitral valve).Since this adverse event might result in permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.
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