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 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation results showed no evidence of a manufacturing problem with the device.Evidence showed that the handpiece was rotated/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.An x-ray taken of the patient did not identify the presence of a needle fragment.

Event Description

An electrode from the guidance handpiece (model number 5300, lot number t160407) broke during the procedure at (b)(6) hospital with dr.(b)(6).The event occurred during handpiece placement into a 5cm fibroid that the doctor considered tough.The dr.Deployed (1.5cm) and felt resistance.While retracting the array, the dr.Had difficulty and stated he felt a snap.This occurred after the 11th ablation.The handpiece was withdrawn from the patient for inspection and it would not deploy past 1.5cm.

• 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: 5835081
• MDR Text Key: 50816010
• Report Number: 3006443171-2016-00004
• 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: 07/29/2016

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: 04/29/2018
• Device Model Number: 5300
• Device Catalogue Number: 5300
• Device Lot Number: 160407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2015
• 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