MAUDE Adverse Event Report: GALIL MEDICAL LTD. ICESPHERE¿ 1.5 CX 90° CRYOABLATION NEEDLE

Model Number	FPRPR3573
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Two needles were used in a cryoablation procedure.During the freeze cycle, frost started to collect on the needle shaft.The user dropped saline on the skin near the insertion site of the needle for the remainder of the case to prevent injury.The case was completed with no injury to the patient.As there was a mix up and the user is unsure which needle was defective, both needles will be returned to the manufacturer for investigation.This mdr is being submitted for the needle from lot t0205 used in this procedure.Please see mdr # 9616793-2020-00067 for the needle from lot t0458.
Additional Manufacturer Narrative
The needle was returned to the manufacturer for investigation.The shaft temperature was within specifications.Review of the needle lot manufacturing records did not identify any vacuum sleeve malfunctions wtihin 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: ICESPHERE¿ 1.5 CX 90° CRYOABLATION NEEDLE
• Common Device Name: CRYOABLATION NEEDLE
• Manufacturer (Section D): GALIL MEDICAL LTD.; 1 tavor building; p.o. box 224, industrial park; yokneam, 20692 03; IS 2069203
• MDR Report Key: 9884043
• Report Number: 9616793-2020-00068
• Device Sequence Number: 2784742
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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: 09/21/2021
• Device Model Number: FPRPR3573
• Device Catalogue Number: FPRPR3573
• Device Lot Number: T0205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 05/03/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1