MAUDE Adverse Event Report: HALT MEDICAL INC. ACESSA HANDPIECE

Model Number 2000

Device Problems No Display/Image (1183); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2014

Event Type  malfunction  

Event Description

During the course of the investigation of a loss of thermocouple readings during a case on (b)(6) 2014, first preliminary investigation pointed to a possible simple error in manufacturing like a lack of contact point caused by, possibly, the thin wires separating from the tip, etc.It turned out on (b)(6) 2014, that the loss of the reading is due to a series of events where in there is an anatomy issue with an unstable, "rolling" fibroid which caused the physician (who was in her second case and still being proctored) to move the handpiece in and out of the fibroid, unknowingly manipulating and twisting the handpiece while partly deployed.This then caused severe stresses to the needles specially one of the needles that ended up breaking.This broken needle then jammed at the distal end causing internal stresses to the slider brackets causing it to break loose which made it conducive for the thermocouple wires to break and display no temperature readings.Therefore, the factors contributing to the root cause of the needle breaking comprised of: anatomy of the fibroid - unstable, rolling fibroid, which are usually difficult for new physicians to stabilize.A doctor who is still new to the procedure, having most likely inadvertently twisted and manipulated the handpiece while partially deployed.The same doctor continued the case with a new handpiece and this time were able to treat the fibroid without any issues.The procedure went well and there were no issues reported regarding the patient's health during or after the procedure at this time after at least about 2-3 follow-ups after the case has been completed.The proctor continues to have communications with the trainee to ensure no other issues have come up regarding the case.So far the doctor and patient related to the case has not exhibited or shown any dissatisfaction with the device or the procedure.The issue was not repeated again with this doctor in subsequent fibroid treatments.

Manufacturer Narrative

Training program already states not to manipulate or twist, etc.When the handpiece's needles are deployed.Re-creation of the issue showed that this is a definite case factor in the needle breaking issue.This combined with the constant moving and instability of the target fibroid, caused unnecessary stresses to the device's nitinol needle, which then bent excessively to the point of breakage.

• Brand Name: ACESSA HANDPIECE
• Type of Device: ACESSA HANDPIECE
• Manufacturer (Section D): HALT MEDICAL INC.; 131 sand creek road suite b; brentwood CA 94513
• Manufacturer Contact: clarisa tate ; 131 sand creek road suite b; brentwood, CA 94513 ; 9252710626
• MDR Report Key: 3807271
• MDR Text Key: 19768671
• Report Number: 3006443171-2014-00002
• Device Sequence Number: 1
• Product Code: HFG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2015
• Device Model Number: 2000
• Device Catalogue Number: 2000
• Device Lot Number: T130101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2014
• Initial Date FDA Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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