MAUDE Adverse Event Report: GALIL MEDICAL LTD ICEROD® PLUS NEEDLE; CRYOABLATION NEEDLE

Model Number	FPRPR3510
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned and could not be investigated.Vacuum sleeve failure is a known potential malfunction with some cryoablation needles.The risk to the patient is the potential for a skin burn due to frost on the needle shaft.Galil medical's labeling includes precautions instructing users to protect the skin with warm saline, when appropriate.There was no patient injury reported.If additional information becomes available a followup report will be filed.
Event or Problem Description
As part of a clinical trial data review performed on (b)(6) 2017, it was discovered that during a cryoablation procedure, the doctor noticed the shaft of one of the needle started to collect frost.There were no earlier notifications or other information provided.There were no known consequences reported to the patient.

• Brand Name: ICEROD® PLUS 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: 7333066
• Report Number: 9616793-2018-00017
• Device Sequence Number: 148167
• Product Code: GEH
• UDI-Device Identifier: 07290104830570
• UDI-Public: 07290104830570
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2018

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 Model Number: FPRPR3510
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1