A male pt of unk age presented for an lecd thermal ablation of the pancreas on (b)(6)2014.Procedure was successfully completed with no reports of complications or device malfunctions.It was reported that approx 12 hours post procedure, the pt experienced bleeding at the ablation site.Info provided indicates the treating physician believed that the procedure caused damage to the duodenum.It was reported that approx three weeks later, the pt expired.The reported disposable device is not available for return to the mfr for eval as it was disposed of by the user.
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This medwatch is not to report a device malfunction, but to report a pt death.Angiodynamics is attempting to obtain add'l info in regards to the event.It was reported that the disposable device was discarded by the user and is not available to be returned to the mfr for eval.An investigation into the root cause of this incident is currently in progress.The results of the device eval will be sent via a follow up medwatch.A review of the device history records for the disposable probes was performed for any deviations related to the reported event.The review confirms that the lots met all material, assembly, and performance specs.
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