MAUDE Adverse Event Report: GALIL MEDICAL LTD. ICEEDGE 2.4 90 CRYOABLATION NEEDLE; CRYOABLATION NEEDLES

Model Number	FPRPR3506
Medical Device Problem Codes	Failure to Fire (2610); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The needle was returned to galil for investigation.Manufacturing records were reviewed and no anomalies were noted.Visual inspection noted that the returned needle was slightly bent.Freezing performance testing was conducted and the needle met all specifications.The failure could not be confirmed and no failure was noted with the needle.
Event or Problem Description
Prior to a cryoablation procedure, one iceedge and two icerod needles tested fine with no issues.However, during the 1st freeze cycle the iceball on the edge needle was very small.The physician continued to use all needles to complete the procedure, but doctor was not happy with the performance of the iceedge.There was no injury to the patient.

• Brand Name: ICEEDGE 2.4 90 CRYOABLATION NEEDLE
• Common Device Name: CRYOABLATION NEEDLES
• Manufacturer (Section D): GALIL MEDICAL LTD.; 1 tavor building, po box 224; industrial park; yokneam, 20692 03; IS 2069203
• MDR Report Key: 6637765
• Report Number: 9616793-2017-00036
• Device Sequence Number: 231619
• Product Code: GEH
• UDI-Device Identifier: 07290104830594
• UDI-Public: 07290104830594
• Combination Product (Y/N): N
• PMA/510(K) Number: K111859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 03/15/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 11/30/2017
• Device Model Number: FPRPR3506
• Device Lot Number: B7455-001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2017
• Initial Report FDA Received Date: 06/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1