MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ICESEED 1.5 CX 90 DEGREES CRYOABLATION NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	H7493967433170
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the frost occurred on the shaft of the needle.An iceseed 1.5 cx 90 degrees cryoablation needle was chosen for a cryoablation procedure to treat a nerve for pain management.During the first freezing cycle, frost was observed on the iceseed 1.5 cx 90 degrees cryoablation needle and the frost was touching the patient's skin.The physician applied saline to the area to dissolve the ice, and the patient's skin did not appear to be affected by the event.The procedure was completed with the original device and frost was not observed again on the shaft of the needle.There were no patient complications as a result of this event.
Event or Problem Description
It was reported the frost occurred on the shaft of the needle.An iceseed 1.5 cx 90 degrees cryoablation needle was chosen for a cryoablation procedure to treat a nerve for pain management.During the first freezing cycle, frost was observed on the iceseed 1.5 cx 90 degrees cryoablation needle and the frost was touching the patient's skin.The physician applied saline to the area to dissolve the ice, and the patient's skin did not appear to be affected by the event.The procedure was completed with the original device and frost was not observed again on the shaft of the needle.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Product investigation results: the device involved in this event was not returned for analysis.However, during good faith effort (gfe) communications, a photo of the needles in use at the time of the irregular ice formation during the procedure was submitted from the user.One of the needles used in the photo does appear to have frost forming on the needle shaft.The reported event was confirmed via the photographic evidence.

• Brand Name: ICESEED 1.5 CX 90 DEGREES CRYOABLATION NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; tavor building number 1, yokne; yokneam 20692 03; IS 2069203
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23148522
• Report Number: 2124215-2025-67355
• Device Sequence Number: 9937656
• Product Code: GEH
• UDI-Device Identifier: 00191506032692
• UDI-Public: (01)00191506032692(17)260519(10)36156181
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: 05/19/2026
• Device Model Number: H7493967433170
• Device Catalogue Number: H7493967433170
• Device Lot Number: 0036156181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 10/30/2025
• Date Device Manufactured: 05/19/2024
• 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 Sex: Unknown