MAUDE Adverse Event Report: GALIL MEDICAL LTD. ICEPEARL 2.1 CX 90° CRYOABLATION NEEDLE; CRYOSURGICAL DEVICES AND ACCESSORIES

Model Number FPRPR3601

Device Problem Failure to Fire (2610)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2020

Event Type  malfunction  

Event 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 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 icepearl cx needle that was used during the case.Please refer to mdr # 9616793-2020-00050 for the icesphere cx needle used during this procedure.

Event Description

This mdr is to document the manufacturer's actions of the icesphere cx needle used in the reported event.Further investigation or follow-up is not planned for this complaint.Please see mdr # 9616793-2020-00049 for the investigation outcome of the icepearl cx needle used in this event.

Manufacturer Narrative

The needle was not returned to the manufacturer, and the reported complaint could not be confirmed.Manufacturing record review was not performed as the lot number is unavailable.

• Brand Name: ICEPEARL 2.1 CX 90° CRYOABLATION NEEDLE
• Type of Device: 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: 9772620
• MDR Text Key: 182551437
• Report Number: 9616793-2020-00050
• Device Sequence Number: 1
• Product Code: GEH
• UDI-Device Identifier: 07290104830990
• UDI-Public: 07290104830990
• Combination Product (y/n): N
• PMA/PMN Number: K152133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FPRPR3601
• Device Catalogue Number: FPRPR3601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1