MAUDE Adverse Event Report: BTG YOKNEAM ICEROD CX 90 DEGREE NEEDLE/VL; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3533
Medical Device Problem Codes	Gas/Air Leak (2946); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the testing phase, six needles from the same lot had a hissing sound.This icerod cx 90 degree needle/vl was selected for a renal cryoablation procedure.During the testing phase, while outside the patient, the needles hissed like there was an air leak along the needle.A new needle was used to complete the procedure successfully without sequela.
Additional Manufacturer Narrative
Device eval by manufacturer: it was initially reported that six needles from the same lot had a hissing sound, however the six needles that were returned and audible noise was confirmed were from two lots (u3242 and u3235).This icerod 1.5 cx 90 degree needle (u3242) was returned for analysis.Visual inspection of the exterior of the needle was performed and no abnormalities were found.The needle was connected to the icefx console, and a two-minute confidence test was performed.The test performed normally.A high-pitched noise was heard during the confidence test, but no gas leaking was observed.Vibrations of the heat exchanger can be heard as a rattling or hissing sound.This sound has no effect on performance or safety of the device.A five-minute freeze in gel was performed to analyze ice ball formation.It was noted that the ice ball formation looked normal and resulted in an ice ball that measured within specification for the icerod 1.5 cx 90 degree needle.The device passed the two-minute confidence test, produced an ice ball of sufficient size.Even though the audible noise was observed, an air leak along the needle was not confirmed.
Event or Problem Description
It was reported that during the testing phase, six needles from the same lot had a hissing sound.This icerod cx 90 degree needle/vl was selected for a renal cryoablation procedure.During the testing phase, while outside the patient, the needles hissed like there was an air leak along the needle.A new needle was used to complete the procedure successfully without sequela.

• Brand Name: ICEROD CX 90 DEGREE NEEDLE/VL
• 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): GALIL ISRAEL; tavor bldg 1; yoenaem 20692 03; IS 2069203
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16218441
• Report Number: 2124215-2023-02159
• Device Sequence Number: 14939766
• Product Code: GEH
• UDI-Device Identifier: 07290104830587
• UDI-Public: 07290104830587
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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: 07/12/2023
• Device Model Number: FPRPR3533
• Device Catalogue Number: FPRPR3533
• Device Lot Number: U3242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown