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

Model Number	FPRPR3533
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D3: manufacturer address 1: tavor building 1, industrial park.G1: mfr site address 1: tavor building 1, industrial park.
Event or Problem Description
It was reported that there was frost on the needle shaft.An icerod cx 90 degree needle/vl was selected for a right paravertebral mass cryoablation procedure to treat a soft tissue mass in the prostate.During the procedure, the needle started freezing with the other needles used together.However, it was observed that the icerod cx 90 degree needle/vl had ice forming on the needle shaft.To prevent frostbite, the needle was exchanged for another to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
D3: manufacturer address 1: tavor building 1, industrial park.G1: mfr site address 1: tavor building 1, industrial park.Device evaluation by manufacturer: an icerod 1.5 cx 90 degree needle (29777828) was returned to arden hills cis for analysis.Visual inspection of the exterior of the needle showed no abnormalities.The needle was connected to the icefx console, and a two-minute confidence test was performed without any abnormal functionality.A five-minute freeze cycle was performed, and it was found that the needle shaft became completely covered in frost.The needle was disassembled, and the vacuum sleeve was tested for vacuum integrity.The vacuum sleeve became covered in frost, meaning the vacuum sleeve was defective.The vacuum sleeve was inspected under a microscope, and it was found that the vacuum sleeve had abnormalities in the metal that likely led to the vacuum integrity failing.The reported event of frost on the needle shaft was confirmed.
Event or Problem Description
It was reported that there was frost on the needle shaft.An icerod cx 90 degree needle/vl was selected for a right paravertebral mass cryoablation procedure to treat a soft tissue mass in the prostate.During the procedure, the needle started freezing with the other needles used together.However, it was observed that the icerod cx 90 degree needle/vl had ice forming on the needle shaft.To prevent frostbite, the needle was exchanged for another 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; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; yokneam 20692 03; IS 2069203
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17625623
• Report Number: 2124215-2023-45798
• Device Sequence Number: 7302126
• Product Code: GEH
• UDI-Device Identifier: 07290104830587
• UDI-Public: 07290104830587
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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: 07/03/2024
• Device Model Number: FPRPR3533
• Device Catalogue Number: FPRPR3533
• Device Lot Number: 0029777828
• 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: 08/04/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female