MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NW ABLATION SYSTEM, US; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	NWC1US1N
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Renal Failure (2041); Swelling/ Edema (4577)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that three months post op the patient experienced loss of kidney function in the ablated kidney.No other information is available.
Additional Manufacturer Narrative
(b)(4).Event date: unknown; captured as awareness date.Batch #: unknown.The following information was requested, but unavailable: how was the initial ablation performed? (such as: how many probes, power level setting, time setting, etc).Were there any device issues during the ablation procedure? where was the location of the kidney tumor? what do they mean by loss of kidney function? is there complete loss of function or abnormal kidney function? was any post ablation imaging performed to confirm size of ablation zone? if yes, what does the ablation zone look like? is there any plan to treat the loss of kidney function? if so, how? what is the patient's current status? an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.As part of ethicon's quality process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.If the product or additional information is received at a later date, the investigation will be updated as applicable.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/18/2022.Additional information was requested and the following was obtained: how was the initial ablation performed? (such as: how many probes, power level setting, time setting, etc.) - 1 probe see below : pr20xt probe used.The same neuwave mobile microwave ablation system was used in both cases.Highly mobile system nm18nea00690.Were there any device issues during the ablation procedure? - no noticeable issues during procedure.Where was the location of the kidney tumor? - rt middle pole anterior.What do they mean by loss of kidney function? is there complete loss of function or abnormal kidney function? - 1st patient lasix mag 3 renogram shows 9% function on affected kidney, ct scan and us w/ hydronephrosis.- 2nd patient lasix mag 3 renogram show 10% function on affected kidney, ct scan and us w hydronephrosis.Was any post ablation imaging performed to confirm size of ablation zone? if yes, what does the ablation zone look like? - no enhancement of ablation zone.Is there any plan to treat the loss of kidney function? if so, how? - tbd.What is the patient's current status? -tbd.Call home was reviewed for system nm18nea00690 on (b)(6) 2021 (5 deliveries).A pr20xt, nm21nhc25824, was connected to channel 3, tested, and put into tissu-loc.An ablation was set to 10:00 at 65w.The user stopped this at 5:50 but resumed and completed it with no errors.Another ablation was set to 10:00, 65w.After 1:58, there was a reflected power error.The user restarted this and another such error was issued immediately.The ablation was restarted and completed after 3:00 with no errors.Temperatures were normal throughout the case (90c-125c).The root cause of the reflected power errors is unknown.The root cause of the patient's loss of kidney function is unknown.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/30/2022.Additional information was requested and the following was obtained: mid pole over 2 cm 1 probe pr 20 xt probe no blood flow into the kidney either collecting system damage post op film and asymptomatic hydronephrosis- mild renal atrophy at the site, exophytic clear cell carcinoma 14 minutes call home was reviewed for system nm18nea00690 on 7/20/21 (5 deliveries).A pr20xt, nm21nhc25824, was connected to channel 3, tested, and put into tissue-loc.An ablation was set to 10:00 at 65w.The user stopped this at 5:50 but resumed and completed it with no errors.Another ablation was set to 10:00, 65w.After 1:58, there was a reflected power error.The user restarted this and another such error was issued immediately.The ablation was restarted and completed after 3:00 with no errors.Temperatures were normal throughout the case (90c-125c).The root cause of the reflected power errors is unknown.The root cause of the patient's loss of kidney function is unknown.This complaint was reported to have taken place in july of 2021.System nm18nea00690 returned for routine maintenance on 2/3/22 for investigation.No repairs were needed.

• Brand Name: NW ABLATION SYSTEM, US
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• Manufacturer (Section G): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• Manufacturer Contact: kara ditty-bovard ; 3529 anderson st; madison, WI 53704 ; 6107428552
• MDR Report Key: 13581544
• Report Number: 3008769756-2022-00004
• Device Sequence Number: 12182662
• Product Code: NEY
• UDI-Device Identifier: 00853719006753
• UDI-Public: 00853719006753
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NWC1US1N
• Device Catalogue Number: NWC1US1N
• Device Lot Number: NM18NEA00690
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2022
• Supplement Date Received by Manufacturer: 02/22/2022; 03/23/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 03/19/2022; 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown