MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-24 for NANOKNIFE SINGLE ELECTRODE PROBE, 15CM 20300101 20400101 manufactured by Angiodynamics.
[6023328]
As reported (b)(6) 2015, a (b)(6), male pt presented for a nanoknife ablation of the liver lesion. During the procedure, it was noted the pt's pulse and blood pressure decreased. Per info provided, the pt had experienced a mild case of bradycardia during pulse delivery. The treating physician paused the energy delivery and the bradycardia self-corrected. The treating physician elected to abort the procedure. There were no report of problem with the generator or probes. Post procedure it was reported the pt was stable and suffered no permanent harm or injury due to the event.
Patient Sequence No: 1, Text Type: D, B5
[13307972]
There was no malfunction of the nanoknife system (generator, probes, and accusync). No part of the system was returned for evaluation. There was no allegation of a device malfunction. During the nanoknife procedure the pt experienced an episode of bradycardia during pulse delivery. The nanoknife generator user manual lists bradycardia as a potential adverse effect. As reported, the treating physician paused the energy delivery, and the pt self corrected. The procedure was aborted. The pt was reported as stable post procedure and discharged normally with no additional tests or concerns from this event. A review of the disposable device history records for the single use probes was performed for any deviations related to the reported event. The review confirms that the lots met all material, assembly, and performance specifications. A review of the service history for the nanoknife generator used during the event noted no repairs, servicing and/or upgrades have been made since the unit was installed at the account. A review of the angiodynamics complaint system noted no trends for this event type and product family. The type of complaint will continue to be monitor ed for trends. Complaint # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2015-00294 |
| MDR Report Key | 4883553 |
| Report Source | 05 |
| Date Received | 2015-06-24 |
| Date of Report | 2015-06-04 |
| Date of Event | 2015-06-04 |
| Date Mfgr Received | 2015-06-04 |
| Date Added to Maude | 2015-07-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAN ANDERSON |
| Manufacturer Street | 603 QUEENSBURY AVE. |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187981215 |
| Manufacturer G1 | ANGIODYNAMICS, INC. |
| Manufacturer Street | 603 QUEENSBURY AVE. |
| 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 SINGLE ELECTRODE PROBE, 15CM |
| Generic Name | LOW ENERGY DIRECT CURRENT ABLATION DEVIC |
| Product Code | OAB |
| Date Received | 2015-06-24 |
| Model Number | 20300101 |
| Catalog Number | 20400101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-06-24 |