MAUDE Adverse Event Report: ANGIODYNAMICS, INC. ANGIODYNAMICS SOLERO MW PROBE; SOLERO PROBE MICROWAVE TISSUE ABLATION APPLICATOR

Model Number H7877001060020

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/17/2022

Event Type  Injury  

Event Description

Retained ceramic tip of the microwave ablation probe within liver tumor.

• Brand Name: ANGIODYNAMICS SOLERO MW PROBE
• Type of Device: SOLERO PROBE MICROWAVE TISSUE ABLATION APPLICATOR
• Manufacturer (Section D): ANGIODYNAMICS, INC.
• MDR Report Key: 14021157
• MDR Text Key: 288691986
• Report Number: 14021157
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7877001060020
• Device Catalogue Number: H7877001060020
• Device Lot Number: 5708790
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2022
• Distributor Facility Aware Date: 03/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Race: White