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

Model Number	FPRPR3508
Medical Device Problem Codes	Insufficient Cooling (1130); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an additional surgery was required after insufficient ice was observed.Three icerod plus 90 degree needles were used in a liver cryoablation procedure.The spacing between the needles was 1.5 cm.During the procedure, however, it was noticed that there was a delay in the ice formation, and the iceball was smaller than was expected.Despite changing the needles to other channels and other troubleshooting measures, the needles still did not freeze.Due to the insufficient ice coverage, the procedure was not able to be completed, and another was scheduled for a later date.The repeat surgery resolved the incident, and no patient complications were reported.
Additional Manufacturer Narrative
D3: manufacturer address 1: (b)(4).Device evaluation by manufacturer: an icerod plus 90 degree needle (30371229) was returned to the arden hills complaint investigation site (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.The device passed the two-minute confidence test, produced an ice ball of sufficient size.A five-minute freeze in gel was performed to analyze ice ball formation.It was noted that the ice ball formation looked normal and resulted in an ice ball that measured approximately 21mm x 43mm, which is within specification for the icerod plus 90 degree needle.The reported complaint was not confirmed.
Event or Problem Description
It was reported that an additional surgery was required after insufficient ice was observed.Three icerod plus 90 degree needles were used in a liver cryoablation procedure.The spacing between the needles was 1.5 cm.During the procedure, however, it was noticed that there was a delay in the ice formation, and the iceball was smaller than was expected.Despite changing the needles to other channels and other troubleshooting measures, the needles still did not freeze.Due to the insufficient ice coverage, the procedure was not able to be completed, and another was scheduled for a later date.The repeat surgery resolved the incident, and no patient complications were reported.

• Brand Name: ICEROD PLUS 90 DEGREE NEEDLE
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17931786
• Report Number: 2124215-2023-56720
• Device Sequence Number: 15056896
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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: 10/07/2024
• Device Model Number: FPRPR3508
• Device Catalogue Number: FPRPR3508
• Device Lot Number: 0030371229
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 70 KG