MAUDE Adverse Event Report: GALIL MEDICAL LTD ICEEDGE 90 DEGREE, SINGLE NEEDLE; CRYOABLATION NEEDLE

Model Number	FPRPR3506
Medical Device Problem Codes	Failure to Fire (2610); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Prior to a renal cryoablation procedure, 2 iceedge 90 degree needles and system tested fine with no issues to report.During the first freeze cycle one needle did not create ice as expected.The iceball was reportedly small.The needle was re-positioned and the same issue occurred during the second and third freeze cycle.The procedure was completed with both needles as expected with no injury to the patient.
Additional Manufacturer Narrative
The needle was returned for investigation.The manufacturing records were reviewed and no related deviation or concerns were found.The reported complaint of no ice creation was not confirmed as the needle passed all investigative testing.The freezing properties and ice ball size were found within specification.The device operated within specification.

• Brand Name: ICEEDGE 90 DEGREE, SINGLE NEEDLE
• Common Device Name: CRYOABLATION NEEDLE
• Manufacturer (Section D): GALIL MEDICAL LTD; 1 tavor building, p.o. box 224; industrial park; yokneam,, israel 20692 ; IS 20692
• MDR Report Key: 7184365
• Report Number: 9616793-2018-00002
• Device Sequence Number: 13710059
• Product Code: GEH
• UDI-Device Identifier: 07290104830594
• UDI-Public: 07290104830594
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K111859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

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
• Operator of Device: Physician
• Device Expiration Date: 05/15/2019
• Device Model Number: FPRPR3506
• Device Lot Number: B9370-015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1