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.
[19911903]
Treated our 9th pt with ire today. Pt had (b)(6) induced cirrhosis, a 2 cm hcc and is currently doing well. However, during the course of the treatment, several probes moved deeper by 4-6 cm despite close observation. No definite complications of the multiple probe migrations are currently apparent. Will continue to observe. This probe motion deeper into the liver occurred several times and was observed by clinical applications specialist. As i mentioned, this inability to lock the probes in place could lead to even more serious complications. While ire does not injure collagen or elastin, there can be mechanical injury, the probes could move deeper or move out. Potentially leading to lacerations of delicate or vital structures such as bile ducts, ureters, bowel, diaphragm, lung, or vessels. It also makes the treatment areas unreliable since the probes move during the pulses. This could lead to untreated areas. A spacer is not an answer since the probes can move out and since the space would need to be variable. The needles need to be fixed either mechanically with tines or frozen as per (b)(4) with co2. No cardiac issues were noted.
Patient Sequence No: 1, Text Type: D, B5
[20095917]
Conclusion: based on the reported complaint, it appears as if the ire probes performed as intended, but during the procedure, the probes moved. The exact cause of the complaint appears to be design related. It is possible the movement of the probes was caused due to respiration or cable weight. Currently there is nothing in the design to prevent the probes from moving. Manufacturing and product development have been made aware to this complaint. 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 the event is not greater than usual.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2010-00020 |
| MDR Report Key | 1690036 |
| Report Source | 05,07 |
| Date Received | 2010-05-07 |
| Date of Report | 2010-05-04 |
| Date of Event | 2010-03-24 |
| 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 | 1. Required No Informationntervention | 2010-05-07 |