MAUDE Adverse Event Report: GALIL MEDICAL LTD. ICEPEARL 2.1 CX 90 DEGREE NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3601
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that frost on the needle shaft occurred.Three icepearl 2.1 cx 90 degree needles were tested successfully and used to perform a percutaneous renal ablation procedure.During the first freeze cycle, one of the needles had ice forming on the entire needle shaft to the skin.The physician wrapped the needles with sterile gauze at the skin and continuously irrigated the needle with saline during both freeze cycles.The treatment was completed with no evidence of patient injury.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for engineering analysis and the complaint was confirmed for 'frost on shaft'.The shaft temperature of -11.5 degrees c points to insufficient thermal insulation of the needle.The needle was disassembled to determine the cause.There were no visible soldering gaps or voids seen.A leak was not found on the vacuum sleeve external surface and no soldering flux residuals or signs of corrosion were noted.The testing verified there was insufficient vacuum insulation of the sleeves.Ice ball size was tested to be within the specification and was not compromised due to this loss of thermal insulation.
Event or Problem Description
It was reported that frost on the needle shaft occurred.Three icepearl 2.1 cx 90 degree needles were tested successfully and used to perform a percutaneous renal ablation procedure.During the first freeze cycle, one of the needles had ice forming on the entire needle shaft to the skin.The physician wrapped the needles with sterile gauze at the skin and continuously irrigated the needle with saline during both freeze cycles.The treatment was completed with no evidence of patient injury.

• Brand Name: ICEPEARL 2.1 CX 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL LTD.; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• MDR Report Key: 11607728
• Report Number: 2134265-2021-04177
• Device Sequence Number: 14275822
• Product Code: GEH
• UDI-Device Identifier: 07290104830990
• UDI-Public: 07290104830990
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 06/02/2022
• Device Model Number: FPRPR3601
• Device Catalogue Number: FPRPR3601
• Device Lot Number: U0596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1