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 2019-11-21 for SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (29CM) H7877001060030 manufactured by Angiodynamics.
[169827388]
As the reported device was not returned, angiodynamics is unable to perform a device evaluation. The customer's reported complaint description cannot be confirmed given the nature of the sharps event; no sample was returned for evaluation. The sharps event occurred when clinician was taking the probe out of the device packaging so there was no biohazard concern. The likely root cause of this incident is end user training. This is the only reported complaint of clinician sharps event for the solero probe product family in the past 15 months, as such, it is deemed to be an isolated incident. Correction/corrective actions: no correction is required since the complaint sample was not returned for evaluation and root cause of this event is likely due to clinician training. Angiodynamics' territory manager was present for this incident and provided in-service education regarding the probe and its packaging. A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint. The review confirms that the lots met all material, assembly, and performance specifications. Labeling review: warning: contents supplied sterile using an ethylene oxide (eo) process. Do not use if sterile barrier is damaged. If damage is found, call your sales representative. Inspect prior to use to verify that no damage has occurred during shipping. For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy. A review of the angiodynamics complaint system noted no trends for this complaint type and product family. This type of complaint will continue to be monitored for trends. Complaint # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[169827389]
As reported : no direct patient impact, nurse was stuck/injured by tip when unpackaging the probe. Rn opening solero 29cm unaware tip not protected. Not informed by angiodynamics' rep. In room at the time of the event. Rn was stuck by tip of device while removing from housing unit in packaging, causing a sharps injury. Second device was opened. Angiodyanmics' rep. Was present and advised of the event afterward. It was reported the disposable device is not available for return to the manufacturer for a device evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317056-2019-00149 |
| MDR Report Key | 9355763 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-21 |
| Date of Report | 2019-11-21 |
| Date of Event | 2019-11-05 |
| Date Mfgr Received | 2019-11-05 |
| Device Manufacturer Date | 2019-08-26 |
| Date Added to Maude | 2019-11-21 |
| 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 | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal | 12801 |
| Manufacturer Phone | 5187424488 |
| Manufacturer G1 | ANGIODYNAMICS |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (29CM) |
| Generic Name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Product Code | NEY |
| Date Received | 2019-11-21 |
| Catalog Number | H7877001060030 |
| Lot Number | 5519185 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | 10 GLENS FALLS TECHNICAL PARK GLENS FALLS NY 12801 US 12801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-21 |