MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-06 for NANOKNIFE SYSTEM 20300101-US manufactured by Angiodynamics.
[91087471]
It was reported that the nanoknife system involved in the incident will not be returned to the manufacturer for evaluation as there was no malfunction. The results of the unit evaluation will be sent via a follow up medwatch. This medwatch is not to report a device malfunction, but to report an adverse patient effect. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[91087472]
As reported to angiodynamics on (b)(6) 2017: this medwatch is not to report a device malfunction, but to report an adverse patient effect. During a nanoknife procedure of the liver, the treating physician had placed the probes near the patient's heart. When pulsing the probes with electrical voltage, the patient went into afib. The probe had been pulsed approximately 20 times prior to the event. The patient's heart rate was greater than 105. The patient was given a beta blocker iv for the afib, and a second attempt was made using lesser voltage. After 10 pulses, the afib started again. The procedure was aborted. The doctor was delivering chemo directly to the area as well during the procedure as it was a combination therapy procedure. The patient was reported as stable post procedure. It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2017-00110 |
| MDR Report Key | 7002889 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-06 |
| Date of Report | 2017-12-28 |
| Date of Event | 2017-10-12 |
| Date Mfgr Received | 2017-10-13 |
| Date Added to Maude | 2017-11-06 |
| 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 |
| 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 SYSTEM |
| Product Code | OAB |
| Date Received | 2017-11-06 |
| Catalog Number | 20300101-US |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | 603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-06 |