MAUDE Adverse Event Report: NEUWAVE MEDICAL, INC. NEUWAVE PR PROBE 15CM 17GA; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number PR15

Device Problems Break (1069); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 9/3/2020.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 were the indications for the ablation procedure? how many probes were used in procedure? what was the approach/where anatomically was the probe inserted? was there any resistance felt or any challenges inserting the probe? where in the liver is the probe tip located? are copies available of any imaging performed? was the postoperative patient care changed or any other treatment required? are there plans to remove the broken probe tip? what is the current status of the patient?.

Event Description

It was reported that during a microwave ablation of the liver, the tip of a pr15 broke off inside of the patient and was not retrieved.Patient was not harmed in any other way.

Manufacturer Narrative

(b)(4).Date sent: 10/5/2020.What were the indications for the ablation procedure? colorectal mets how many probes were used in procedure? 2.What was the approach/where anatomically was the probe inserted? anterior through lower sternum, between ribs.Was there any resistance felt or any challenges inserting the probe? no.Where in the liver is the probe tip located? not in liver, but in soft tissue are copies available of any imaging performed? potentially? the site would have to be contacted.Was the postoperative patient care changed or any other treatment required? no.Are there plans to remove the broken probe tip? no.What is the current status of the patient? i am not aware of the patient¿s condition.

Manufacturer Narrative

(b)(4).Date sent: 10/5/2020.Investigation summary: no errors were seen in call home.No probe will be returned to neuwave for further investigation since it was discarded.The issue of the broken probe tip could not be verified.Call home was reviewed for system nm13nea00217 on 8/5/20.There were two cases on this date.Case 1: a pr15xt, nm19nhb94504, was connected to channel 3, tested successfully, and was put into tissu-loc.Another pr15xt, nm19nhb94528, was connected to channel 2, tested successfully, and was put into tissu-loc.An ablation was set to 10:00, 65w for both probes.This completed with no errors.Cauterize was completed and this marked the end of the case.Case 2: a pr15, nm19ncb93654, was connected to channel 3, tested successfully, and was put into tissu-loc.A 10:00, 65w ablation was completed.A pr20xt, nm19nhc84395, was connected to channel 2 and tested successfully.Cauterize was completed on probe 3 (twice), and the probe was disconnected.Probe 2 was put into tissu-loc and was set to ablate at 10:00, 65w.The user stopped the ablation at 5:54.From this point on in the case, the tissu-loc temperatures were a little more sporadic than normal, but no errors were seen.This probe completed a 5:00, 65w ablation with no errors.The probe was disconnected and this marked the end of the case.

• Brand Name: NEUWAVE PR PROBE 15CM 17GA
• Type of Device: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): NEUWAVE MEDICAL, INC.; 3529 anderson st; madison 53704
• MDR Report Key: 10488367
• MDR Text Key: 205735753
• Report Number: 3008769756-2020-00024
• Device Sequence Number: 1
• Product Code: NEY
• UDI-Device Identifier: 00853719006395
• UDI-Public: 00853719006395
• Combination Product (y/n): N
• PMA/PMN Number: K160936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PR15
• Device Catalogue Number: PR15
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention