MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-10-21 for NANOKNIFE SYSTEM 203100101 manufactured by Angiodynamics, Inc..
[58057892]
It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation. An investigation into the root cause of this incident is currently in progress. The results of the device evaluation will be sent via a follow up medwatch. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[58057893]
As reported september 27, 2016, a male patient of unknown age presented for an ire (irreversible electroporation) procedure for a pelvic mass. The ire procedure was successfully completed with no report of complications or device malfunction. The patient was discharged 5 days after the ire. He had some s1 nerve injury but was reported as walking with some assistance and getting physical therapy. Post procedure, it was reported his plastic ureteral stent had broken in two at the ire site. It appeared to have had melted into two pieces. The patient's stent was removed and replaced. It was reported that the patient suffered no adverse effects due to the event. It was reported the nanoknife system is available for return to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[71875027]
As the reported device was not returned, angiodynamics is unable to perform a device evaluation. The customer's reported complaint of possible melting to ureteral stent during the ire treatment could not be confirmed because no sample was received for evaluation. Without a device evaluation, a root cause for the event cannot be determined. There was no report of patient complication or device malfunction during the procedure. The reporting facility did not indicate the batch/lot number of the affected product. As a result, a search for similar complaints of the same lot/batch could not be performed. The nanoknife generator user manual states that adverse effects that may be associated with the use of the nanoknife system include, but are not limited to: "arrhythmia , hemorrhage, infection, damage to critical anatomical structure (nerve, vessel, duct), pneumothorax, unintended mechanical perforation, bradycardia, muscle contraction, vagal stimulation, asystole, adverse effect may occur but has not been reported" 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2016-00143 |
| MDR Report Key | 6046890 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-10-21 |
| Date of Report | 2017-03-23 |
| Date of Event | 2016-09-19 |
| Date Mfgr Received | 2016-09-27 |
| Date Added to Maude | 2016-10-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAW RYAN |
| Manufacturer Street | 603 QUEENSBURY AVENUE |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187424488 |
| Manufacturer G1 | ANGIODYNAMICS, INC. |
| Manufacturer Street | 603 QUEENSBURY AVENUE |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NANOKNIFE SYSTEM |
| Generic Name | LOW ENERGY DIRECT CURRENT ABLATION DEVICE |
| Product Code | OAB |
| Date Received | 2016-10-21 |
| Model Number | 203100101 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS, INC. |
| Manufacturer Address | 603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-10-21 |