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

Model Number	FPRPR3533
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a gas leak was detected in the tip of the needle.An icerod cx 90 degree needle/vl was selected for a cryotherapy procedure.When checking the needles, however, there was a leak detected at the tip of the needle.The needle was exchanged for another needle of the same model to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: an icerod 1.5 cx 90 degree needle (lot# 29981581) was returned for analysis.Visual inspection of the exterior of the needle was performed and no abnormalities were initially noticed.The needle was connected to the icefx console, and a two-minute confidence test was performed.It was discovered during this confidence test that air was leaking from the needle connector.The needle connector was disassembled, and it was found that the o-rings had slipped off of the wire, where they are supposed to be located.The o-rings were placed in their correct orientation and the leak disappeared.The reported event of gas leaking from the needle tip was unable to be confirmed; however, it was discovered that the console connector was confirmed to be leaking gas.Upon reorienting the displaced o-rings, the leaking gas stopped.
Event or Problem Description
It was reported that a gas leak was detected in the tip of the needle.An icerod cx 90 degree needle/vl was selected for a cryotherapy procedure.When checking the needles, however, there was a leak detected at the tip of the needle.The needle was exchanged for another needle of the same model 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; tavor bldg 1, industrial park; 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16564814
• Report Number: 2124215-2023-11988
• Device Sequence Number: 12236197
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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: 08/10/2024
• Device Model Number: FPRPR3533
• Device Catalogue Number: FPRPR3533
• Device Lot Number: 0029981581
• 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: 03/10/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown