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

Model Number PR15XT

Device Problems Break (1069); Material Separation (1562); Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/29/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Maude report number: mw5094423.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device history review: lot ml20024980 was reviewed (in process sn (b)(4)).Manufacture date: 3/10/2020.Expiration date: 11/1/2023.Additional information was requested, and the following was obtained: were they able to remove easily the tip from the patient? no.The tip was left inside the patient.They did a ct scan and they didn¿t feel that it was a threat to the patient.Did the patient experience any adverse consequences due to this issue? no.Was ultrasound guidance used for probe placement? were multiple probes being used? what was the approach/where anatomically was the probe inserted? was there any resistance felt or any challenges inserting the probe? are copies available of any imaging performed? what was the anticipated ablation time? does the doctor feel the 7 minutes was adequate? thank you for following up.We can only share that the probe tip fractured off and couldn¿t be retrieved from the patient¿s liver.We would be unable to share any additional patient information.

Event Description

It was reported that during a liver ablation procedure, customer was using pr15xt ablation probe.Seven minutes into case, doctor received "reflective power" error and turned it off.Tip of probe broke off in patient.Probe was removed and ended case.It is unknown if there are any patient complications.

Manufacturer Narrative

(b)(4).Date sent: 3/28/2023.Investigation summary call home revealed reflected power errors and probe temperature too high errors.No device will be returned to neuwave for further investigation.The potential cause of the errors seen is unknown.Lot ml20024980 was reviewed (in process (b)(6)).Manufacture date: 3/10/20.Expiration date: 11/1/23.There were no problems seen during the manufacturing and testing of this lot.A search of nonconformities (ncs) was performed for lot ml20024980.There were no observed nonconformities for this lot.

• Brand Name: NEUWAVE PR XT PROBE 15CM 15GA
• Type of Device: 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 53704 ; 6107428552
• MDR Report Key: 10100709
• MDR Text Key: 192732624
• Report Number: 3008769756-2020-00019
• Device Sequence Number: 1
• Product Code: NEY
• UDI-Device Identifier: 00853719006401
• UDI-Public: 853719006401
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PR15XT
• Device Catalogue Number: PR15XT
• Device Lot Number: ML20024980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention