MAUDE Adverse Event Report: GALIL MEDICAL LTD. ICESPHERE 1.5 CX CRYOABLATION NEEDLES; CRYOSURGICAL DEVICES AND ACCESSORIES

Model Number	FPRPR3573
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
One icepearl cx cryoablation needle was used for a left renal lesion (1.2cm mass).An additional icesphere cx needle was introduced in the third freeze cycle of the procedure.Both needles passed testing, with no leaks, a uniform iceball, with correct formation followed by proper thawing.No error message occured during the needle test.A biopsy was performed prior to freezing, and the needle positioning was confirmed with ct with no critical structures were observed near the planned ablation zone.The iceball was not visible throughout the procedure.No fluctuation in needle temperature, freezing percentage and gas pressure was observed throughout the entire procedure.Contrast was produced in the fourth cycle, but no iceball was visible.The user specifically noted that ice was not visible at the following timepoints: first freeze - 5 minutes, first freeze - 8 minutes, second freeze, third freeze, fourth freeze.After the procedure, the needles were then tested by being submerged in basin of water, and tested successfully with ice immediately forming.There was no indication of a freezing error, needle leak or needle clog.The needles were kept and will be returned to the manufacturer for investigation.At the post scan of the procedure, no enhancement or bleeding was observed.The user decided to wait at the follow-up scan to determine if the ablation was successful.The patient has not experienced any complications.This report is being filed conservatively on the premise that the treatment may not have been successful, and a new treatment may have to be planned for this case.This mdr is for the icesphere cx needle that was used during the case.Please refer to mdr # 9616793-2020-00049 for the icepearl cx needle used during this procedure.
Additional Manufacturer Narrative
The needle was not returned to the manufacturer, and the reported complaint could not be confirmed.Manufacturing record review did not identify any malfunctions related to freezing performance within the needle batch.
Event or Problem Description
This mdr is to document the manufacturer's actions of the icepearl cx needle used in the reported event.Further investigation or follow-up is not planned for this complaint.Please see mdr # 9616793-2020-00050 for the investigation outcome of the icesphere cx needle used in this event.

• Brand Name: ICESPHERE 1.5 CX CRYOABLATION NEEDLES
• Common Device Name: CRYOSURGICAL DEVICES AND ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL LTD.; 1 tavor building; p.o. box 224, industrial park; yokneam, 20692 03; IS 2069203
• MDR Report Key: 9772614
• Report Number: 9616793-2020-00049
• Device Sequence Number: 2573998
• Product Code: GEH
• UDI-Device Identifier: 07290104831133
• UDI-Public: 07290104831133
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2020

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: 08/22/2021
• Device Model Number: FPRPR3573
• Device Catalogue Number: FPRPR3573
• Device Lot Number: T0033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 02/29/2020
• Supplement Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1