MAUDE Adverse Event Report: 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that frost on the needle shaft occurred.An icepearl 2.1 cx 90 degree needle was in use during a breast cryoablation procedure when during the second freeze cycle frost was visible on the needle shaft, as well as, the hub and cables.The patients skin was already being managed with warm water in a sterile glove and checked by the physician.No adverse event occurred as a result and the procedure was completed successfully.
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned for engineering analysis.It was confirmed shaft temperature points to insufficient thermal insulation of the needle.The ice ball size was within specs and was not compromised due to thermal insulation loss.The soldering joint to shaft was inspected, and no visible soldering gaps or voids were found.A vacuum sleeves insulation test was performed, and ice formed on the entire sleeves.Microscopic examination of the vacuum sleeve surface revealed no soldering flux residuals or corrosive signs.A vacuum sleeve bubble test was performed, and no leak was found on the vacuum sleeve external surface.The complaint was confirmed.The investigation testing results showed insufficient vacuum insulation of the vacuum sleeves.
Event or Problem Description
It was reported that frost on the needle shaft occurred.An icepearl 2.1 cx 90 degree needle was in use during a breast cryoablation procedure when during the second freeze cycle frost was visible on the needle shaft as well as the hub and cables.The patient's skin was already being managed with warm water in a sterile glove and checked by the physician.No adverse event occurred as a result and the procedure was completed successfully.

• Brand Name: ICEPEARL 2.1 CX 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• MDR Report Key: 12372233
• Report Number: 2134265-2021-10520
• Device Sequence Number: 11765989
• Product Code: GEH
• UDI-Device Identifier: 07290104830990
• UDI-Public: 07290104830990
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

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: 03/14/2023
• Device Model Number: FPRPR3601
• Device Catalogue Number: FPRPR3601
• Device Lot Number: U2422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 11/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1