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

Model Number	FPRPR3533
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An icerod 1.5 cx 90 degree needle was returned to the boston scientific complaint investigation site without an associated complaint.However, the device evaluation revealed frost on the needle shaft.
Additional Manufacturer Narrative
D3: manufacturer address 1- tavor building 1, industrial park.Device evaluation by mfr.: an icesphere 1.5 90 degree needle (lot #29757957) was returned 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 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 for abnormalities.It was found that the vacuum sleeve was completely bent within the straight needle shaft and had a flattened side that ran through the whole vacuum sleeve.The event of frost on the needle shaft was identified and traced to a faulty vacuum sleeve.

• 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; tavor bldg number 1; yokneam 20692 03; IS 2069203
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16828570
• Report Number: 2124215-2023-17418
• Device Sequence Number: 7131813
• Product Code: GEH
• UDI-Device Identifier: 07290104830587
• UDI-Public: 07290104830587
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2023

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: 07/02/2024
• Device Model Number: FPRPR3533
• Device Catalogue Number: FPRPR3533
• Device Lot Number: 0029757957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown