MAUDE Adverse Event Report: GALIL MEDICAL LTD ICEFORCE 2.1 CX 90° CRYOABLATION NEEDLE

Model Number	FPRPR3602
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Muscle Spasm(s) (1966)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that three needles were used for a renal cryoablation procedure.The needles were tested with no issues.During the first freeze cycle, one of the needle's caused the patient to twitch.The case was completed as expected.The needles will be returned for investigation.
Additional Manufacturer Narrative
Three needles were returned to the manufacturer for investigation.The electrical parameters were outside of specifications for one of the three needles, confirming the reported complaint.Needle disassembly identified the root cause as damage to the insulation layer of the heater wire.Review of the needle lot manufacturing records identified 7 electrical malfunctions within the needle batch.
Event or Problem Description
This mdr is to document the manufacturer's investigation of the needle used in the reported event.Further investigation or follow-up is not planned for this complaint.

• Brand Name: ICEFORCE 2.1 CX 90° CRYOABLATION NEEDLE
• Common Device Name: CRYOABLATION NEEDLE
• Manufacturer (Section D): GALIL MEDICAL LTD; 1 tavor building; p.o. box 224; industrial park, 20692 03; IS 2069203
• MDR Report Key: 9547949
• Report Number: 9616793-2020-00002
• Device Sequence Number: 16715141
• Product Code: GEH
• UDI-Device Identifier: 07290104831089
• UDI-Public: 07290104831089
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K162599
• 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): 04/29/2020

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: 07/21/2021
• Device Model Number: FPRPR3602
• Device Catalogue Number: FPRPR3602
• Device Lot Number: A7050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 04/05/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1