MAUDE Adverse Event Report: ANGIODYNAMICS SOLERO; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	700106002-US
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A territory manager reported an end user experienced an issue when using a 19 cm solero applicator.The customer claims that the ceramic tip of the solero applicator broke off in liver at the end of a ct guided microwave ablation procedure.Case details - ct guided percutaneous ablation of liver (hcc) in which two separate lesions were treated.The applicator was tested prior to use and placed with no resistance or difficulty.2 ablations were performed.First lesion was burned twice, once for 4 minutes at 140 w and again for 4 more minutes at 100 w.The second lesion was also burned twice, both times the lesion was treated for 2 minutes at 140 w.No error codes appeared during the procedure.The applicator was withdrawn and inspected between the 2nd and 3rd ablations.Looked normal when repositioning between liver segments 5 and 8 to target the second lesion.They believe the tip detached during the last ablation.A paracentesis procedure was also performed at the same time as the mwa procedure.Treating physicians, dr.(b)(6) (radiologist) and dr.(b)(6) (5th yr resident), state that the ablation treatments were both successfully completed.They also report that the issue was not identified until after post images were taken at which point it was determined that "fragments" of the applicator were left in the liver.Treating mds then sent the patient over to ir to have the "fragments" removed.Customer states that two of the three "fragments" were successfully removed and that it was decided to leave the last one in place.Customer also claims that while the patient will continue to be monitored, he/she is currently doing well.Dr.(b)(6) and dr.(b)(6) have both been trained on the system and both have years of experience with the procedure/system, but between the two dr.Munger has more.Total time of the ablation was for the whole procedure was 12 minutes total time.
Additional Manufacturer Narrative
The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
Received one (1) 19cm probe.The applicator was received with the shaft was bent and the tubing and coax cable severed from the handle as if cut.The cartridge and tubing was removed and not returned.A portion of the ceramic tip, semi rigid center conductor, ceramic cylinder and end washer have detached.Approximately 4 mm of ceramic tip remains attached to portion of semi rigid protruding for the shaft.It was not possible to understand the root cause for the tip detachment and whether this device was or was not used as indicated by the dfu.Unable to determine whether manufacturing defect was present or other failure mode occurred due to its condition as received.A thermal event did occur, but the true failure mode is not able to be determined.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the instructions for use, item number {16600972-01} 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."the solero microwave tissue ablation (mta) system and accessories are indicated for the ablation of soft tissue during open procedures.Avoid placing lateral forces on the applicator tip during placement or removal.Always use the lowest power and shortest time necessary to achieve the targeted ablation.Inspect the applicator after each ablation.If the applicator appears damaged, utilize another applicator for subsequent ablations.Warning: when placing the device, use the minimum force necessary and take care not to over advance the applicator.Refer to the shaft depth markings to monitor placement depth.Take care to not bend the tip as it may cause damage to the device.Do not energize the applicator unless the active region of the applicator is fully inserted into target tissue.If the applicator is not properly located into the selected tissue, an unintended thermal injury may occur.After each ablation inspect the applicator for any damage.If any damage is observed the applicator should be discarded and replaced with a new applicator." the solero microwave tissue ablation (mta) system and accessories are indicated for the ablation of soft tissue* during open, laparoscopic, or percutaneous procedures.Reference (b)(4).
Additional Manufacturer Narrative
The new information does not impact the investigation results previously sent on report 1317056-2024-00163-01.Reference (b)(4).
Event or Problem Description
(b)(4) was received.New information: two-lesion ablation performed with paracentesis.First lesion was burned twice, 140 watts for 4 mins and 100 watts for 4 mins.A 6 french drain was then placed for paracentesis during ablation of second lesion.While draining, probe was positioned into second lesion.Two burns performed at second lesion, 140 watts for 4 mins.After final ablation on second lesion, track ablation was performed to remove probe.Scan performed to evaluate liver and fluid in abdomen.Surgeon noticed metallic object on the scan image and notified attending surgeon.Ct technologist removed probe from sharps container and found the probe without a tip.Attending surgeon attempted to remove tip of probe but was unsuccessful.Technologist notified interventional radiology department which made room to accommodate the patient.Patient left room under anesthesia.
Additional Manufacturer Narrative
Reference (b)(4).

• Brand Name: SOLERO
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 20514311
• Report Number: 1317056-2024-00163
• Device Sequence Number: 17943104
• Product Code: NEY
• UDI-Device Identifier: H787700106002US0
• UDI-Public: H787700106002US0
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K162449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 700106002-US
• Device Lot Number: 5819774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 10/23/2024; 11/07/2024; 12/23/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 10/28/2024; 11/12/2024; 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male