MAUDE Adverse Event Report: GALIL MEDICAL LTD. ICESPHERE 1.5 CX 90 DEGREE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3573
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an icesphere needle had frost on the shaft during the first freeze cycle of a renal cryoablation procedure.The physician stopped the procedure and replaced the needle with another icesphere.The case was completed without any patient injury.
Additional Manufacturer Narrative
The device was returned for engineering analysis.The investigation testing results showed insufficient vacuum insulation of the sleeves resulting in the frost on the shaft.Soldering flux residuals with signs of corrosion was seen on the vacuum sleeve external surfaces; however no gas leaks were detected.The iceball size was within specification and was not compromised due to the thermal insulation loss.Device analysis found no evidence that the vacuum loss phenomena was caused by these findings or during the assembly process and there was no evidence that the needle was damaged after the initial testing by the user.
Event or Problem Description
It was reported that an icesphere needle had frost on the shaft during the first freeze cycle of a renal cryoablation procedure.The physician stopped the procedure and replaced the needle with another icesphere.The case was completed without any patient injury.

• Brand Name: ICESPHERE 1.5 CX 90 DEGREE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL LTD.; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• MDR Report Key: 10204303
• Report Number: 2134265-2020-08600
• Device Sequence Number: 2297706
• Product Code: GEH
• UDI-Device Identifier: 07290104831133
• UDI-Public: 07290104831133
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K181741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: Health Professional
• Device Expiration Date: 12/07/2021
• Device Model Number: FPRPR3573
• Device Catalogue Number: FPRPR3573
• Device Lot Number: T0567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 06/27/2020
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1