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

Model Number	FPRPR3533
Medical Device Problem Codes	Insufficient Cooling (1130); Insufficient Heating (1287); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that a needle shaft leak occurred.An icerod cx 90 degree needle/vl was selected for a renal cryoablation procedure.During preparation, the needle was being tested when an ithaw malfunction displayed.The testing phase was continued.But the same needle had about 5 air bubbles around the needle shaft and no ice formed.The needle was then removed and replaced with another needle, that worked as expected to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
D3: manufacturer address 1- tavor building 1, industrial park.Device evaluated by manufacturer: an icerod 1.5 cx 90 degree needle (30081810) was returned to arden hills cis for analysis.Visual inspection of the exterior of the needle was performed and no abnormalities were noted.The needle was connected to the icefx console, and a two-minute confidence test was performed, and it was discovered during this test that the device had an error message saying 'i-thaw needle is defective for electrical thawing.' no gas leak or abnormal ice formation was noticed during the two-minute confidence test.The needle was disassembled and evaluated under a microscope for abnormalities.Abnormalities in the heater wire including charring of the wire and discoloration were noticed.The i-thaw error message and the abnormal wire conditions are indicative of the reported i-thaw failure; therefore, the reported event was confirmed.
Event or Problem Description
It was reported that a needle shaft leak occurred.An icerod cx 90 degree needle/vl was selected for a renal cryoablation procedure.During preparation, the needle was being tested when an ithaw malfunction displayed.The testing phase was continued, but the same needle had about 5 air bubbles around the needle shaft and no ice formed.The needle was then removed and replaced with another needle that worked as expected 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16991975
• Report Number: 2124215-2023-21758
• Device Sequence Number: 20599886
• Product Code: GEH
• UDI-Device Identifier: 07290104830587
• UDI-Public: 07290104830587
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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: 08/22/2024
• Device Model Number: FPRPR3533
• Device Catalogue Number: FPRPR3533
• Device Lot Number: 0030081810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown