MAUDE Adverse Event Report: BTG YOKNEAM ICEPEARL 2.1 CX 90 DEGREE NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3601
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the ithaw and cautery options were unavailable and bleeding occurred requiring additional intervention.An icefx cryoablation system and three icepearl 2.1 cx 90 degree needles were selected for the treatment of renal cell carcinoma.The first freeze cycle was performed in the kidney, followed by passive and fast thaw cycles.The gas tank was changed.The second freeze cycle with passive thaw was completed.The gas tank was changed again.An ithaw error occurred and both ithaw and cautery options were unavailable (greyed out on screen).Troubleshooting was performed but both i-thaw and cautery were still unavailable and to use passive thaw.The physician easily removed the needles after 6-8 minutes of passive thaw.As soon as the needles were removed, the patient started bleeding.Pressure and a non-bsc embolization gelatin were used in the needles tracks, down to the kidney.An arterial computed tomography (ct) scan was performed to check that the bleeding had stopped.The procedure was cut short as another freeze cycle on another area of the lesion had been planned.The patient was then extubated and sent overnight to the ward for observation.Two days post-procedure, the patient had a repeat ct scan, which showed where the bleed was, and that the bleeding had stopped.The patient's hemoglobin had decreased.The biopsy was not easy and had to be performed twice.

• Brand Name: ICEPEARL 2.1 CX 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): BTG YOKNEAM; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15232081
• Report Number: 2134265-2022-08469
• Device Sequence Number: 6447156
• Product Code: GEH
• UDI-Device Identifier: 07290104830990
• UDI-Public: 07290104830990
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Report Date (Section B): 08/16/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: FPRPR3601
• Device Catalogue Number: FPRPR3601
• Device Lot Number: U2494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown