MAUDE Adverse Event Report: BTG YOKNEAM Icepearl 2.1 CX L 90 Degree Needle; Unit, Cryosurgical, Accessories

Model Number	FPRPR3617
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	11/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event- publish date selected detailed product information was not provided to bsc.Because the product lot number is unknown, we are unable to provide the complete unique identifier (udi) #.Harris, j., will, r., robinson, e., & finley, d.S.(2025).Rectal spacer gel displacement of the rectum during prostate cryoablation: a case series.Journal of urologic oncology, 23(3), 247-252.Https://doi.Org/10.22465/juo.255000900045.
Event or Problem Description
It was reported that cellulitis occurred, requiring intervention.The purpose of this article was to describe a novel case series using rectal spacer gel to displace and protect the rectum during prostate cancer cryoablation.Fifty men with clinically localized grade group 1-5 prostate cancer underwent concurrent rectal spacer gel and primary (n=27) or salvage (n=23) prostate cryoablation using the spaceoar hydrogel and icepearl (2.1 mm/14 gauge) and/or iceseed (1.5 mm/17 gauge) cryoablation needle(s).Of the 50 cases, there was only one case with a complication of perineal cellulitis, as a clavien-dindo grade ii complication.The cellulitis was able to be resolved with an incision and drainage of the fluid collection and antibiotics.There were no further complications observed.
Event or Problem Description
It was reported that cellulitis occurred, requiring intervention.The purpose of this article was to describe a novel case series using rectal spacer gel to displace and protect the rectum during prostate cancer cryoablation.Fifty men with clinically localized grade group 1-5 prostate cancer underwent concurrent rectal spacer gel and primary (n=27) or salvage (n=23) prostate cryoablation using the spaceoar hydrogel and icepearl (2.1 mm/14 gauge) and/or iceseed (1.5 mm/17 gauge) cryoablation needle(s).Of the 50 cases, there was only one case with a complication of perineal cellulitis, as a clavien-dindo grade ii complication.The cellulitis was able to be resolved with an incision and drainage of the fluid collection and antibiotics.There were no further complications observed.
Additional Manufacturer Narrative
B3: date of event- publish date selected.Detailed product information was not provided to bsc.Because the product lot number is unknown, we are unable to provide the complete unique identifier (udi) #.Harris, j., will, r., robinson, e., & finley, d.S.(2025).Rectal spacer gel displacement of the rectum during prostate cryoablation: a case series.Journal of urologic oncology, 23(3), 247-252.Https://doi.Org/10.22465/juo.255000900045.Investigation results: 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 review of the cryoablation needle device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.

• Brand Name: Icepearl 2.1 CX L 90 Degree Needle
• Common Device Name: Unit, Cryosurgical, Accessories
• Manufacturer (Section D): BTG YOKNEAM; tavor building 1; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): Galil Medical Ltd.; tavor bldg. 1; industrial park; yokneam, 20692 03; IS 2069203
• Manufacturer Contact: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 25896682
• Report Number: 2124215-2026-39350
• Device Sequence Number: 13297244
• Product Code: GEH
• UDI-Device Identifier: 07290104831072
• UDI-Public: (01)07290104831072
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FPRPR3617
• Device Catalogue Number: FPRPR3617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Supplement Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 09/01/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown