MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE PR XT PROBE 20CM 15GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	PR20XT
Medical Device Problem Codes	Material Twisted/Bent (2981); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent ablation with 2pr xt probes (20cm) for 10 minutes 65watt each.After the procedure the probes were repositioned.Started a second cycle for 5 minutes and an error message appeared after two +/- 2 minutes on one of the probes (no contact error).The second probe could still ablate but gave an error message one minute later.They tried to reconnect the probes after error message.They could not ablate anymore with the probes.A reflective power message was there.After removing the probe we¿ve noticed one was in a 90 degree angle.
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Additional information was requested and the following was obtained: what was the location of tumor? liver, segment vii what approach was taken for probe placement? ct guided percutaneous intercostal approach.Was any resistance felt during insertion? no resistance what was the reason for repositioning probes? we did a pull back because of insufficient proximal treatment to increase the size of the ablation zone is it known how the probe became bent at 90-degree angle? no.After first ablation pullback and imaging confirmation of needle positions (intact needles).Then ablation and removal after ablation.After removal confirmation scan with fragments.What is the location of broken probe tip? cranially in the ablation zone are there plans to remove broken tip? no can imaging be shared? yes, anonymous on cdrom investigation summary there was no call home available.Probe nm20nhc19946 (11:55) was investigated at neuwave.The probe had a broken probe tip-still attached.The root cause of the broken probe tip is unknown lot ml20115794 was reviewed (in process sn (b)(4)).Manufacture date: 11/19/2020.Expiration date: 7/31/2024.There were no problems during the manufacturing and testing of this lot.Analysis does not reveal the root cause of the reported failure.No further investigation will be conducted on this complaint.Complaint information will be included in complaint trending that is reviewed by the applicable pqss drb on a regular basis to determine if further action is necessary.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/23/2021 investigation summary call home revealed a probe temperature too high error and multiple reflected power errors.The probe returned with a broken probe tip-still attached.The root cause of the broken probe tip is unknown.Lot ml20115794 was reviewed (in process sn 9).Manufacture date: 11/19/20 expiration date: 7/31/24 there were no problems during the manufacturing and testing of this lot.Analysis does not reveal the root cause of the reported failure.No further investigation will be conducted on this complaint.Complaint information will be included in complaint trending that is reviewed by the applicable pqss drb on a regular basis to determine if further action is necessary.

• Brand Name: NEUWAVE PR XT PROBE 20CM 15GA
• 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: 12600977
• Report Number: 3008769756-2021-00092
• Device Sequence Number: 4023754
• Product Code: NEY
• UDI-Device Identifier: 00853719006425
• UDI-Public: 00853719006425
• Combination Product (Y/N): N
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

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: PR20XT
• Device Catalogue Number: PR20XT
• Device Lot Number: ML20115794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown