SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (14CM)
Report
- Report Number
- 1317056-2020-00063
- Event Type
- Injury
- Date Received
- April 8, 2020
- Date of Event
- March 13, 2020
- Report Date
- September 8, 2020
- Manufacturer
- ANGIODYNAMICS
- Product Code
- NEY
- PMA / PMN Number
- K162449
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
THIS REPORT IS BEING SUBMITTED TO ADD DATE NEW INFORMATION WAS RECEIVED. COMPLAINT # : (B)(4).
RETURNED FOR EVALUATION WAS A SOLERO PROBE. FUNCTIONAL TESTING OF THE DEVICE NOTED NO ISSUES. THE PROBE FUNCTIONED AS INTENDED. THE PROBE WAS CONNECTED TO THE QBY COMPLAINT LAB GENERATOR AND RUN WITH NO ISSUES. AT 140W SETTING DELIVERED POWER WAS SHOWING 128-131W. THIS IS A TYPICAL RANGE. THERE WAS A SMALL AREA OF COATING ON THE METAL SHAFT JUST PROXIMAL OF THE CERAMIC TIP THAT SHOWED SOME DELAMINATION. THIS WOULD NOT BE A CAUSE OF ANY POWER ISSUE BUT MAY BE CAUSED BY A THERMAL EFFECT. THE DEVICE WAS NOT FURTHER DECONSTRUCTED TO ALLOW PROPER FUNCTIONING FOR ANY ADDITIONAL TESTING. NO DEFICIENCIES FOUND. PROBE WAS FUNCTIONALLY TESTED ON R&D GENERATOR AND THE RETURNED GENERATOR S/N QBY0001995 USED DURING THE PATIENT EVENT AT THE END USER FACILITY. THERE WERE NO ABNORMALITIES IN THE DISPLAYED POWER OUTPUT DURING THIS TESTING. THE APPLICATOR PROBE AND GENERATOR COMBINATION WAS OBSERVED TO BE WORKING NORMAL. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION COULD NOT BE CONFIRMED DUE TO THE NATURE OF ABLATION SIZE FAILURE MODE AND EVALUATION OF THE RETURNED PROBE (B)(4) AND GENERATOR (B)(4). THE REPORTED COMPLAINT OF A LARGER THAN EXPECTED ABLATION SIZE CANNOT BE CONFIRMED BECAUSE OF AN INABILITY TO RECREATE ALL FACTORS THAT GO INTO AN IN-VIVO ABLATION. FACTORS THAT CAN AFFECT AN ABLATION SIZE ARE LISTED BELOW: PROBE PLACEMENT AND PROBE MOVEMENT DURING PLACEMENT. TISSUE TYPE AND MOISTURE CONTENT. VASCULATURE WHICH MAY SKEW AN ABLATION DUE TO EXCESS FLUID ACTING AS A HEAT SINK. GENERATOR POWER OUTPUT. THE ROOT CAUSE OF THE REPORTED COMPLAINT IS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE APPLICATOR LOT ANY DEVIATION IN MANUFACTURING PROCESS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMED THAT THE LOT AND THE ASSOCIATED COMPONENTS USED WITHIN THE LOT ALL CONFORMED TO MANUFACTURING PROCESSES AND TESTING. LABELING REVIEW: THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED TO THE USER WITH THE SOLERO APPLICATORS CONTAINS THE FOLLOWING STATEMENTS; "INSPECT ALL DEVICES AND PACKAGING FOR DAMAGE PRIOR TO USE. DO NOT USE ANY DEVICES THAT ARE DAMAGED OR IF THE STERILE BARRIER IS BREACHED. INSPECT THE SOLERO APPLICATOR'S PRE-ATTACHED TUBING SETS PRIOR TO USE. DO NOT USE THE DEVICE IF THE TUBING SETS HAVE ANY EVIDENCE OF DAMAGE (E.G. KINKS, CRACKS, ETC.). OBTAIN A MINIMUM OF 1000 ML OF STERILE CHILLED SALINE. 3000 ML CHILLED SALINE MAY ALSO BE USED TO INCREASE THE AMOUNT OF TIME BEFORE THE COOLING RESERVOIR NEEDS TO BE REPLACED. STERILE FLUID SHOULD BE CHILLED PRIOR TO PROCEDURE. TO ATTACH THE SINGLE USE TUBING TO A CHILLED-FLUID DELIVERY AND COLLECTION SYSTEM, REMOVE THE CAP ON TUBING SET SPIKE AND INSERT SPIKE IN THE SALINE SOURCE, BEING CAREFUL NOT TO PUNCTURE THROUGH THE SALINE SOURCE. TO ENSURE PROPER FLUID MOVEMENT HANG THE SALINE SOURCE HIGHER THAN THE GENERATOR (SUCH AS ON AN IV POLE). LOAD THE TUBING SET INTO THE SOLERO GENERATOR PUMP. THE PUMP CLIP ON TUBING SHOULD BE LOADED INTO THE PUMP CLIP HOLDER ON THE LEFT SIDE OF THE PUMP AND THEN CLOSE THE PUMP HOUSING COVER. PRIME THE TUBING SET BY TURNING THE PUMP ON AND MAKING SURE THERE ARE NO AIR BUBBLES PRESENT IN THE TUBING SET AND IN THE SALINE BAG PRIOR TO PLACING THE DEVICE IN THE TARGET TISSUE." A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. (B)(4).
THIS REPORT IS BEING SUBMITTED TO ADD DATE NEW INFORMATION WAS RECEIVED. COMPLAINT (B)(4).
AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. COMPLAINT REFERENCE#: (B)(4).
ADDITIONAL INFORMATION OBTAINED DURING THE INVESTIGATION OF THIS EVENT INDICATED THAT THE EVENT MAY HAVE BEEN INFLUENCED BY THE NUMBER OF TIMES THE PATIENT HAD RECEIVED PRIOR ABLATIONS. THE INFORMATION PROVIDED CONFIRMED THE PATIENT HAD EXPERIENCED A PNEUMOTHORAX, RESULTING IN THE ADDITIONAL 4 DAYS OF HOSPITALIZATION.
POST PROCEDURE, THE PATIENT WAS REPORTED AS HAVING AN UNSTABLE AIR LEAK REQUIRING DRAINAGE. THE PATIENT WAS REPORTED AS EXPERIENCING SEVERE PAIN. ACTIONS TAKEN TO RESOLVE PATIENT ISSUE: OBSERVATION, BLOOD/BLOOD PRODUCTS, ANALGESIA, CHEST DRAIN WITH UNDERWATER SEAL HOSPITALIZATION EXTENDED 4 DAYS.
THE REPORTED DEFECTIVE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR A DEVICE EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR PRODUCT PROBLEM IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4).
A MICROWAVE PROCEDURE USING THE SOLERO MICROWAVE SYSTEM WAS PERFORM AN A FEMALE PATIENT'S LUNG. POST PROCEDURE, IT WAS NOTED THE ABLATION ZONE WAS LARGER THAN EXPECTED FOR THE TARGET AREA. THERE WAS NO REPORT OF AN ADVERSE PATIENT EFFECT DUE TO THIS EVENT. IT WAS REPORTED THE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 399094 | SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (14CM) | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES | NEY | ANGIODYNAMICS | 5515110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |