MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-05-07 for IRE SINGLE ELECTRODE PROBE 20400101 manufactured by Angiodynamics.
[1555578]
During the pulse delivery, dr. (b)(6) noticed that two of the four needles were pulling back due to either respiration or cable weight. The two probes pulled back roughly 2cm. Ire treatment was paused mid delivery. Dr. (b)(6) performed additional ct scans to visualize probe location prior to advancing back into place. Probes were re-positioned. Pt was re-scanned to confirm needle placement. Ire treatment was continued. Post ct showed edema in the area of the probe re-traction.
Patient Sequence No: 1, Text Type: D, B5
[8644056]
Conclusion: the exact cause of the complaint is unk. It is possible the movement of the probes was caused due to respiration or cable weight. This is the first reported complaint of this type. The exact cause of the complaint is unk. During the review of the manufacturing records for the possible lots, it was observed that the manufactured lots meet all device specifications and quality requirements. This type of complaint is being evaluated by our engineering group. This type of complaint will continue to be monitored for trends. No further action required at this time. Frequency has increased but the severity of this event is not greater than usual.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2010-00019 |
| MDR Report Key | 1690035 |
| Report Source | 05,07 |
| Date Received | 2010-05-07 |
| Date of Report | 2010-05-04 |
| Date of Event | 2010-02-01 |
| Date Mfgr Received | 2010-02-10 |
| Date Added to Maude | 2011-12-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGARET MCGUIRE |
| Manufacturer Street | 603 QUEENSBURY AVE. |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187981215 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IRE SINGLE ELECTRODE PROBE |
| Generic Name | IRE SINGLE ELECTRODE PROBE |
| Product Code | OHJ |
| Date Received | 2010-05-07 |
| Catalog Number | 20400101 |
| Lot Number | NOT REPORTED |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-07 |