MAUDE Adverse Event Report: ENDOCARE INC. MICROTHERMX MICROWAVE ABLATION SYSTEM; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number SWST-1415

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/07/2019

Event Type  malfunction  

Event Description

15cm st probe tip separated from the antenna at the end of the procedure and was not able to be retrieved from the patient.Doctor asked for tract ablation.Performed for approx 5 seconds without an alarm.Doctor noted the tip of the probe was missing as probe was withdrawn.Immediately ordered a scan and observed probe tip still located in the patient near the level, or even 2 cm "deeper" than its placement in the lesion.Doctor commented probe tip was not removable by him in the ct suite, indicated it would be left in place pending further review.Patient removed from treatment room, sent to recovery.Unknown if further intervention to remove the tip will take place.

Manufacturer Narrative

Actual device evaluated.Visual evaluation confirmed that the probe tip was missing.A cold solder joint between the simi-rigid coaxial cable and the trocar tip caused decaying then intermittent connections with the trocar tip.Arcing and high reflected power increased heat that exceeded the temperature on the melting point of solder and bonding strength of epoxy.The decay of these two points caused the tip to have no mechanical bonding to the antenna shaft thus allowing the tip to remain within the tissue.Multiple attempts to gain further information regarding the patients condition have been unsuccessful.

• Brand Name: MICROTHERMX MICROWAVE ABLATION SYSTEM
• Type of Device: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): ENDOCARE INC.; 9825 spectrum dr.; building 2; austin TX 78717
• Manufacturer (Section G): ENDOCARE INC.; 9825 spectrum dr.; building 2; austin TX 78717
• Manufacturer Contact: deborah wilcoxen ; 9825 spectrum dr.; building 2; austin, TX 78717 ; 5125181743
• MDR Report Key: 8658810
• MDR Text Key: 146908271
• Report Number: 3008262715-2019-00086
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Model Number: SWST-1415
• Device Lot Number: 678B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR