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Model Number 20300101 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problems
High Blood Pressure/ Hypertension (1908); Irregular Pulse (2469)
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Event Date 11/10/2014 |
Event Type
Injury
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Event Description
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As reported on december 05, 2014, on (b)(6) 2014, a (b)(6), male patient presented for a nanoknife treatment or a colon-rectal metastasis to a liver legion.While the nanoknife generator was delivering pulses in, the ecg signal was lost.It was reported that the nanoknife generator delivered several pulses in between the r-waves.It was indicated that the pulse developed an irregular heart rhythm and severe hypertension as a consequence.The treating physician completed the procedure, but stopped treatment three times.The patient was stable post-procedure, but remained in the hospital overnight for cardiac monitoring.He received intravenous blood pressure lowering medication as well as antiarrhythmics.The patient was visited the following day by the cardiologist who prescribed an arrhythmic medication for medical treatment of the hypertension.The patient was transferred to a ward, for continued monitoring.He was released the following day and remains on antihypertensive medication.
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Manufacturer Narrative
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The reported nanoknife unit has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the unit.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.A review of the device history records was performed for the serial number (b)(4).The review confirms that the unit met all material, assembly, and performance specifications at the time of manufacture.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution.A review of the reported complaints for the previous 15 months and the risk management documentation for this device notes that the reported event does not present a risk to patients or user in a frequency or manner which has not been anticipated.This is not considered a systemic failure mode.The user manual, which is supplied with this device, lists arrhythmia as a potential adverse effect that may be associated with the use of the nanoknife system.
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Search Alerts/Recalls
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