MAUDE Adverse Event Report: BTG YOKNEAM ICEPEARL 2.1 CX 90 DEGREE NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3601
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation by manufacturer: the device was visually examined to reveal no initial abnormalities.A full functional test was performed with a 2-minute underwater pretest, a 5-minute freezing test, and a 2-minute active thaw test, and no functional issues were noted during this testing.The freezing test yielded some frost on the non-insulated portions of the handle including just up to the shaft/handle junction.The media provided was reviewed and it appears to show frost formation on the non-insulated handle portions of the device.
Event or Problem Description
It was that pneumothorax occurred, requiring an additional device.An icepearl 2.1 cx 90 degree needle was selected for a cryoablation procedure to treat cancer that had spread to the lungs from the colon.The icepearl 2.1 cx 90 degree needle performed as expected during the testing period and was placed in the patient.Upon placement of subsequent unknown devices, the patient developed a pneumothorax, and a chest tube was placed.After the chest tube was placed, the physician opted to start the freeze cycle for the icepearl 2.1 cx 90 degree needle.During the procedure, frost occurred on the shaft of the device where the needle connects to the handle of the device.The original device was used to complete the procedure.
Event or Problem Description
It was that pneumothorax occurred, requiring an additional device.An icepearl 2.1 cx 90 degree needle was selected for a cryoablation procedure to treat cancer that had spread to the lungs from the colon.The icepearl 2.1 cx 90 degree needle performed as expected during the testing period and was placed in the patient.Upon placement of subsequent unknown devices, the patient developed a pneumothorax, and a chest tube was placed.After the chest tube was placed, the physician opted to start the freeze cycle for the icepearl 2.1 cx 90 degree needle.During the procedure, frost occurred on the shaft of the device where the needle connects to the handle of the device.The original device was used to complete the procedure.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the device was visually examined to reveal no initial abnormalities.A full functional test was performed with a 2-minute underwater pretest, a 5-minute freezing test, and a 2-minute active thaw test, and no functional issues were noted during this testing.The freezing test yielded some frost on the non-insulated portions of the handle including just up to the shaft/handle junction.The media provided was reviewed and it appears to show frost formation on the non-insulated handle portions of the device.
Event or Problem Description
It was that pneumothorax occurred, requiring an additional device.An icepearl 2.1 cx 90 degree needle was selected for a cryoablation procedure to treat cancer that had spread to the lungs from the colon.The icepearl 2.1 cx 90 degree needle performed as expected during the testing period and was placed in the patient.Upon placement of subsequent unknown devices, the patient developed a pneumothorax, and a chest tube was placed.After the chest tube was placed, the physician opted to start the freeze cycle for the icepearl 2.1 cx 90 degree needle.During the procedure, frost occurred on the shaft of the device where the needle connects to the handle of the device.The original device was used to complete the procedure.Additional information provided by the representative through the good faith effort process details that only one cryoablation needle was used in this event.The icepearl 2.1 cx 90 degree needle was placed prior to the pneumothorax.

• Brand Name: ICEPEARL 2.1 CX 90 DEGREE 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 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: 23470794
• Report Number: 2124215-2025-79333
• Device Sequence Number: 9066533
• Product Code: GEH
• UDI-Device Identifier: 07290104830990
• UDI-Public: (01)07290104830990(17)270723(10)37031808
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2026

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: FPRPR3601
• Device Catalogue Number: FPRPR3601
• Device Lot Number: 0037031808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 11/07/2025; 01/27/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/04/2025; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown