MAUDE Adverse Event Report: BTG GALIL MEDICAL 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	11/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was frost on needle shaft.An icepearl 2.1 cx 90 degree needle was selected for use in a cryoablation procedure treating back pain.Two minutes into the first freeze cycle, frost was noticed on the needle shaft.Freezing was stopped, saline was put on the skin, and the needle was thawed and removed from the patient.No sign of frost bite was observed.The procedure was completed with a new needle.No patient complications were reported.
Additional Manufacturer Narrative
Device technical analysis: the complaint device was returned for device analysis.The needle passed a visual inspection.The needle had electric testing which showed potential insufficient thermal insulation of the needle.Disassembly of the needle found no visible soldering gaps or voids; soldering flux was seen on the vacuum sleeve.The root cause appears to be insufficient vacuum insulation of the sleeves.
Event or Problem Description
It was reported there was frost on needle shaft.An icepearl 2.1 cx 90 degree needle was selected for use in a cryoablation procedure treating back pain.2 minutes into the first freeze cycle, frost was noticed on the needle shaft.Freezing was stopped, saline was put on the skin, the needle was thawed and removed from the patient.No sign of frost bite was observed.The procedure was completed with a new needle.No patient complications were reported.

• Brand Name: ICEPEARL 2.1 CX 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG GALIL MEDICAL; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): BTG GALIL MEDICAL; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12927052
• Report Number: 2134265-2021-14971
• Device Sequence Number: 5737421
• Product Code: GEH
• UDI-Device Identifier: 07290104830990
• UDI-Public: 07290104830990
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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: 03/08/2023
• Device Model Number: FPRPR3601
• Device Catalogue Number: FPRPR3601
• Device Lot Number: U2351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown