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

Model Number	FPRPR3618
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Muscle Spasm(s) (1966)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent cryoablation for a renal case with five iceforce needles.The patient was under conscious sedation.During active thaw cycle, the patient experienced muscle spasm.Passive thaw was used to complete the case as expected with no patient injury.It is unknown which needle caused the stimulation; therefore all five needles will be returned for investigation.
Additional Manufacturer Narrative
Five needles were returned to the manufacturer for investigation.One out of five needles exhibited "shorting" beahviour, whereby the heater wire was suspected to be in contact with the needle shaft.The other four needles passed electrical testing, with all electrical parameters within specification.The needle that exhibited "shorting" behaviour showed a high voltage upon initial testing, but further testing showed that the needle performed as expected.The complaint could not be confirmed, and the root cause could not be identified.
Event or Problem Description
This mdr is follow up 1 to reported the investigation findings of the five needles used in this cryoablation case.No further follow-up or investigation is anticipated.

• Brand Name: ICEFORCE¿ 2.1 CX L 90° 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: 9538114
• Report Number: 9616793-2020-00001
• Device Sequence Number: 11356713
• 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): 02/22/2020

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 Model Number: FPRPR3618
• Device Catalogue Number: FPRPR3618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 02/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1