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	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a gas leak from the needle shaft.A icerod cx 90 degree needle/vl was selected for a cryoablation procedure to treat renal cell carcinoma.During integrity testing for preparation, however, the needle started to make a hissing noise.Additionally, upon observation of the needle in the saline bath, two air bubbles were seen coming from the needle shaft.No visible damage was noticed.The needle was not used and was replaced with an icepearl needle to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
D3: manufacturer address 1- tavor building 1, industrial park device evaluation by manufacturer: an icerod 1.5 cx 90 degree needle (29118248) was returned to the arden hills complaint investigation site (cis) 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.A high-pitched noise was heard during the confidence test.Vibrations of the heat exchanger can be heard as kind of rattling or hissing sound.It is normal phenomena and does not affect any needle's performance or safety.No gas leaking was observed.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 approximately 19mm x 44mm, which is within specification for the icerod 1.5 cx 90 degree needle.A two-minute i-thaw cycle was performed, and no error messages were encountered.The i-thaw functionality worked in thawing the ice ball.The device passed the two-minute confidence test, produced an ice ball of sufficient size, and completed an i-thaw cycle with no abnormalities.Even though the noise was observed, an air leak along the needle was not, therefore the reported event was not confirmed.
Event or Problem Description
It was reported that there was a gas leak from the needle shaft.A icerod cx 90 degree needle/vl was selected for a cryoablation procedure to treat renal cell carcinoma.During integrity testing for preparation, however, the needle started to make a hissing noise.Additionally, upon observation of the needle in the saline bath, two air bubbles were seen coming from the needle shaft.No visible damage was noticed.The needle was not used and was replaced with an icepearl needle to complete the procedure.There were no patient complications reported.

• Brand Name: ICEROD CX 90 DEGREE NEEDLE/VL
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; po box 224; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; tavor building number 1; yokneam 20692 03; IS 2069203
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17755223
• Report Number: 2124215-2023-49657
• Device Sequence Number: 7172814
• Product Code: GEH
• UDI-Device Identifier: 07290104830587
• UDI-Public: 07290104830587
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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: 03/16/2024
• Device Model Number: FPRPR3533
• Device Catalogue Number: FPRPR3533
• Device Lot Number: 0029118248
• 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: 08/22/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male