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

Model Number	FPRPR3508
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that frost was observed on the needle shaft.This icerod plus 90 degree needle was selected for a percutaneous cryoablation procedure for residual tumor after tace for liver cancer.During the testing phase, the whole needle was found to be covered with frost.The needle was not used for the procedure; no patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: this icerod plus 90 degree needle was returned for analysis.Visual inspection of the exterior of the needle revealed no abnormalities.The needle was connected to the icefx console, and a two-minute confidence test was performed without any abnormal functionality.Further testing included a five-minute freeze cycle, 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, indicating the vacuum sleeve was defective.The vacuum sleeve was inspected under a microscope for abnormalities revealing discoloration and abnormalities that likely led to the vacuum integrity failing.
Event or Problem Description
It was reported there was frost observed on the needle shaft.This icerod plus 90 degree needle was selected for a percutaneous cryoablation procedure for residual tumor after tace for liver cancer.During the testing phase, the whole needle was found to be covered with frost.The needle was not used for the procedure; no patient complications were reported.

• Brand Name: ICEROD PLUS 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; tavor building 1; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; tavor building number 1, yokne; yokneam 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16016896
• Report Number: 2124215-2022-52902
• Device Sequence Number: 6570449
• Product Code: GEH
• UDI-Device Identifier: 07290104830563
• UDI-Public: 07290104830563
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110946
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: 06/17/2024
• Device Model Number: FPRPR3508
• Device Catalogue Number: FPRPR3508
• Device Lot Number: 0029734560
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG