MAUDE Adverse Event Report: BTG YOKNEAM ICEFORCE 2.1 CX NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3604
Medical Device Problem Codes	Insufficient Heating (1287); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was resistance when removing the needle.This iceforce 2.1 cx needle was selected for use in a cryoablation for renal cell carcinoma.During the procedure, there was an ithaw malfunction during active thawing.The physician waited several minutes before attempting to remove the needle, but upon removal they felt resistance and worried about internal bleeding.The field indicated that the resistance was likely due to not enough time allowed for passive thaw.Bleeding was not evident on post-ct scan, and further follow-up regarding the patient outcome did not reveal any patient complications.

• Brand Name: ICEFORCE 2.1 CX NEEDLE
• 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 bldg number 1; yokneam ; IS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18387579
• Report Number: 2124215-2023-73055
• Device Sequence Number: 2699539
• Product Code: GEH
• UDI-Device Identifier: 07290104831027
• UDI-Public: 07290104831027
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K152133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2023

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 Model Number: FPRPR3604
• Device Catalogue Number: FPRPR3604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown