An angiodynamics clinical services manager reported a patient issue, that occurred post ire ablation procedure.The patient was treated with 7 probes, on their right elbow, for sarcoma.The lesion was, reportedly, close to the median nerve and fairly superficial.An initial ablation was performed, followed by a pullback ablation to ensure the whole lesion was treated.After the procedure was completed, a second degree burn/blister, on the skin, was noted.Wound care was consulted the following day.This medwatch is not to report a device malfunction, but to report an adverse patient effect post procedure.There was no report of a device malfunction or patient complication during the procedure.
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As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The reported nanoknife probe product was not returned to angiodynamics since there was no reported device malfunction.However, the customer supplied a picture of the patient's skin burn.The customer's reported complaint description of patient had skin burn was confirmed via picture provided by end user.Although the reported complaint description is confirmed, the root cause for the event cannot be determined.A device history records review was not conducted since there was no reported lot number, and ship history lot review was not performed since item number is unknown.In addition, there was no reported device malfunction during the procedure.Labeling review: the instructions for use which is supplied to the end user with this catalog number, contains the following statement: "warnings: do not use a device with damaged insulation.Do not attach anything to the device unless it is supplied by angiodynamics and indicated for use with this device.Attachments may damage the insulation and contribute to patient injury.Inspect all of the devices and packaging for damage prior to use.Do not use any devices that are damaged or if the sterile barrier is breached." a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).
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