FDA Adverse Event Malfunction Summary report: N

HS AMICA

MDR report key: 10874843 · Received November 20, 2020

Report

Report Number
10874843
Event Type
Malfunction
Date Received
November 20, 2020
Date of Event
September 29, 2020
Report Date
November 9, 2020
Manufacturer
H.S. HOSPITAL SERVICE SPA
Product Code
GEI
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

ELDERLY MALE PATIENT WITH METASTATIC RENAL CELL CARCINOMA REFERRED FOR PERCUTANEOUS MICROWAVE ABLATION OF A RIGHT UPPER LOBE LUNG METASTASIS. THE PATIENT PRESENTED FOR SCHEDULED ABLATION. THE PROBE WAS PLACED PERCUTANEOUSLY IN/ADJACENT TO THE NODULE IN THE RIGHT UPPER LOBE. CT IMAGES CONFIRMED APPROPRIATE PROBE POSITIONING. THE PLAN WAS TO TREAT FOR APPROXIMATELY 40W AT 5 MINUTES WHICH SHOULD HAVE PROVIDED AN ABLATION ZONE LARGE ENOUGH TO FULLY ENCOMPASS THE LESION WITH A MARGIN. AFTER 5 MINUTES OF TREATMENT AT 40W, INTRA-PROCEDURAL FLUOROSCOPY SHOWED NO CLEAR GROUND GLASS ENCOMPASSING THE LESION (TYPICALLY GROUNDGLASS IS PRESENT AFTER TREATMENT). THEREFORE, TREATMENT WAS CONTINUED FOR AN ADDITIONAL 1 MINUTE AT 40W AND THEN A FINAL MINUTE AT 60W, FOR A TOTAL OF 7 MINUTES. IMAGES WERE ACQUIRED 10 MINUTES AFTER COMPLETING THE 7 MINUTES OF TREATMENT AND STILL NO SIGNIFICANT GROUNDGLASS WAS SEEN SURROUNDING THE LESION. GIVEN THAT EXTRA ENERGY HAD BEEN USED FOR AN EXTENDED TREATMENT OF 7 MINUTES WHICH SHOULD GIVE A MORE THAN ADEQUATE ABLATION ZONE, THE DECISION WAS MADE TO COMPLETE THE PROCEDURE. THE PATIENT HAD A FOLLOW-UP CT WHICH SHOWED THAT THE TREATED NODULE IN THE RIGHT UPPER LOBE HAD NOT SIGNIFICANTLY CHANGED IN SIZE AND THERE WAS NO SIGNIFICANT ABLATION ZONE. GIVEN THAT THE PROBE HAD BEEN APPROPRIATELY PLACED AND THE MACHINE WAS RUN PROPERLY (IN THE PRESENCE OF AMICA REP), THIS IS MOST CONSISTENT WITH A TECHNICAL FAILURE OF THE AMICA ABLATION MACHINE. THE REPRESENTATIVE FROM BOSTON SCIENTIFIC WAS MADE AWARE OF THE EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1341281 HS AMICA ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI H.S. HOSPITAL SERVICE SPA AMICA-PROBE

Patients

Seq Age Sex Outcome Treatment
1 23360 DA Other