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

Model Number	H7493967233100
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft leak occurred.An iceseed 1.5 cx s 90 degree cryoablation needle was selected for an intercostal nerve ablation procedure.Upon performing the initial two-minute test, a tiny bubble could be seen at the distal tip.The needle was exchanged for another needle of a different lot to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Investigation results: device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review performed for the iceseed 1.5 90 degree needle confirmed that the event of gas/air leak is a known event defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Product risk benefit includes consideration of risk severity and rate, and the overall residual risk of the device is acceptable.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unable to exclude device problem.
Event or Problem Description
It was reported that a shaft leak occurred.An iceseed 1.5 cx s 90 degree cryoablation needle was selected for an intercostal nerve ablation procedure.Upon performing the initial two-minute test, a tiny bubble could be seen at the distal tip.The needle was exchanged for another needle of a different lot to complete the procedure.There were no patient complications as a result of this event.

• Brand Name: ICESEED 1.5 CX S 90 DEGREE 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; yokneam 20692 03; IS 2069203
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 24702083
• Report Number: 2124215-2026-16693
• Device Sequence Number: 18751780
• Product Code: GEH
• UDI-Device Identifier: 00191506032678
• UDI-Public: (01)00191506032678(11)250827(17)270827(10)37258389
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/23/2026

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: H7493967233100
• Device Catalogue Number: H7493967233100
• Device Lot Number: 0037258389
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 08/27/2025
• 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