MAUDE Adverse Event Report: HALT MEDICAL, INC. GUIDANCE HANDPIECE

Model Number 5300

Device Problem Material Separation (1562)

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

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation results showed no evidence of a manufacturing problem with the device.Evidence showed that the handpiece was advanced while the needles were deployed causing a sharp bend on the center needle.Retracting the array may have caused the center needle to break.Ifu pl-01-0014, pl-01-0016 and pl-01-0033 provide precautions with regards to positioning and advancing the device while needles are deployed.Training material (pe-00-0102 and pe-00-0103) provides field staff and proctors with precautions with regards to positioning/advancing the device while needles are deployed.

Event Description

An electrode from the guidance handpiece (model number 5300, lot number 160810) broke during the procedure at (b)(6) hospital with dr.(b)(6) the uterus was estimated to be 24 weeks in size.The fibroid being treated was estimated to be between 10cm to 15cm in size.During the handpiece positioning, halt field rep.Observed pushing of the handpiece while needles were deployed and cautioned the doctor to not advance while needles are deployed.The field rep asked the doctor after the 6th or 7th ablation to check the needles, and noticed needle #7 was shorter than the others when fully deployed during a test deployment.On nov.17, 2016, dr.(b)(6) was notified that the missing needle fragment (1.2cm in length) was not located within the device.

• Brand Name: GUIDANCE HANDPIECE
• Type of Device: GUIDANCE HANDPIECE
• Manufacturer (Section D): HALT MEDICAL, INC.; 131 sand creek rd.; suite b; brentwood CA 94513
• Manufacturer (Section G): HALT MEDICAL, INC.; 131 sand creek rd.; suite b; brentwood CA 94513
• Manufacturer Contact: lou tateo ; 131 sand creek rd.; suite b; brentwood, CA 94513 ; 9256347949
• MDR Report Key: 6121703
• MDR Text Key: 60692200
• Report Number: 3006443171-2016-00005
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2016

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: Physician
• Device Expiration Date: 08/10/2018
• Device Model Number: 5300
• Device Catalogue Number: 5300
• Device Lot Number: 160810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1