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

Model Number	FPRPR3560
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	11/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The needle was not returned for investigation.The needle manufacturing records were reviewed and no related deviations or concerns were found.Skin burn is a known adverse event and documented in the product labeling.The patient was treated with topical ointment and no further injury was reported.The ifu instructs the user that is important that a patient's skin is protected from direct contact with needle tubing to avoid the potential for thermal injury to the patient.When preparing to conduct a cryoablation procedure, position the cryoablation system in a manner to avoid draping the tubing across the patient.Ensure an appropriate insulating barrier is placed as needed (such as towels) or other method is employed to prevent needle tubing from touching a patient's skin.
Event or Problem Description
Immediately after a renal cryoablation case, the physician noticed a burn on the skin of the patient close to the isolation sheath due to contact with the skin.Clarification was received that the burn was caused by frost on the grey tubing of the needle.The patient was treated with topical ointment.The needle was not returned for investigation.

• Brand Name: ICESPHERE 1.5 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: 8723626
• Report Number: 9616793-2019-00039
• Device Sequence Number: 16609316
• Product Code: GEH
• UDI-Device Identifier: 07290104830945
• UDI-Public: 07290104830945
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2020
• Device Model Number: FPRPR3560
• Device Catalogue Number: FPRPR3560
• Device Lot Number: A0744-015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other