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	Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent.What was the location of tumor? what approach was taken for probe placement? was any resistance felt during insertion? what was the reason for repositioning probes? is it known how the probe became bent at 90-degree angle? what is the location of broken probe tip? are there plans to remove broken tip? can imaging be shared? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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 where 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.After removal of the probes one probes was found to be broken and the tip was left behind in the patient (seen afterwards on the ct).Distance between probe emitting points was between 1,7 and 1,5 cm.A data call home date transfer has been made and is received.(hospital has a signed call home agreement).Tried to reconnect the probes after error message.Could not ablate anymore with one probe and later the second probe stopped as well.The reflective power message was there.After removing the probes we¿ve noticed one was in a 90 degree angle and the other one was fully broken.On the ct you can see a small piece (7mm long?) of probe left behind in the liver.According to the user it looked deeper than where the probe initially was located.Spacing between the probes was 1,5 ¿ 1,6 cm.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/20/2021.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.Please provide a shipping address / pick up.Investigation summary: since this occurred in the netherlands, there is no call home available.The probe returned with a missing probe tip.The root cause of the missing probe tip is unknown.Lot: ml20115794 was reviewed (in process sn: (b)(6).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.
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 missing probe tip.The root cause of the missing probe tip is unknown.Lot ml20115794 was reviewed (in process sn (b)(6)).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.
Additional Manufacturer Narrative
(b)(4), date sent: 12/8/2021 analysis of the ct images by the mso: i just reviewed multiple series of abdominal ct images with special interest in liver.In several series of images, a tiny metal spot was observed ranging from imaging #100 to #106.The metal spot is located within the liver ablation zone.Per site initial reporting, the spot seen in multiple images represents left over broken probe tip.No other issue noted.

• 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: 12316330
• Report Number: 3008769756-2021-00078
• Device Sequence Number: 4136636
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/16/2021

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: PR20XT
• Device Catalogue Number: PR20XT
• 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: 07/16/2021
• Supplement Date Received by Manufacturer: 08/25/2021; 11/22/2021; 12/07/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/20/2021; 11/23/2021; 12/08/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown