MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-06-11 for ACCUSYNC 27200-5P manufactured by Angiodynamics.
[19586765]
As reported on (b)(6) 2014, a (b)(6) female patient presented for a lecd thermal ablation of the liver. During the ablation, it was noted the patient developed arterial fibrillation. The treating physician determined to continue with the procedure. There was no report of permanent harm or injury to the patient due to the event. The nanoknife system was reported as available for return to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[19822519]
It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation. To date the device has yet to be returned. Attempts are being made to obtain the device. An investigation into the root cause for incident is currently in progress. The results of the investigation will be sent via a follow up medwatch. A review of the device history records was performed for the serial number (b)(4). A review of the device history records for the sulis accusync (serial number (b)(4)) noted no repairs, servicing and/or upgrades since the unit was manufactured. The review confirms that the unit met all material, assembly, and performance specifications. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2014-00083 |
| MDR Report Key | 3874922 |
| Report Source | 06 |
| Date Received | 2014-06-11 |
| Date of Report | 2014-05-26 |
| Date of Event | 2014-05-26 |
| Date Mfgr Received | 2014-05-26 |
| Date Added to Maude | 2014-06-17 |
| 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 |
| 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 | ACCUSYNC |
| Generic Name | LECD THERMAL ABLATION SYSTEM |
| Product Code | OAB |
| Date Received | 2014-06-11 |
| Model Number | 27200-5P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | QUEENSBURY NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-11 |