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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that frost occurred on the needle shaft.An icepearl 2.1 cx 90 degree needle was selected for a renal cryoablation procedure.During the procedure at 2 minutes, it was noticed that the exposed portion of one needle was frosting.The remaining two needles were satisfactory.The affected needle stopped and ablation was completed with the remaining two icepearl needles.All three probes passed the leakage test prior to insertion in the patient.An observation of the skin entry point revealed no injury.There were no patient complications and the patients status was stable.
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).Describe event or problem: additional information updated the following fields with physician information: initial reporter title, initial reporter first name, initial reporter last name, initial reporter email , health professional, occupation.Evaluation by mfr: the complaint device was not returned by the customer.A photo of the complaint needle was provided by the site revealing a needle with a frosted shaft.A frosted shaft as observed, is most likely due to a failure of the vacuum insulation sleeve of the needle.A failure of the vacuum insulation sleeve will not provide sufficient insulation between the gas line and the outer shaft causing frost to appear on the non-treatment zone of the needle.
Event or Problem Description
It was reported that frost occurred on the needle shaft.An icepearl 2.1 cx 90 degree needle was selected for a renal cryoablation procedure.During the procedure at 2 minutes, it was noticed that the exposed portion of one needle was frosting.The remaining two needles were satisfactory.The affected needle stopped and ablation was completed with the remaining two icepearl needles.All three probes passed the leakage test prior to insertion in the patient.An observation of the skin entry point revealed no injury.There were no patient complications and the patients status was stable.It was further reported that the patient's skin was protected with sterile ultrasound jelly.
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).Evaluation by mfr: a photo of the complaint needle was provided by the site revealing a needle with a frosted shaft.The device was returned for analysis.The device was hooked up to the in-house console and functional testing was performed.A 5-minute freeze cycle was performed and frost on the shaft appeared almost instantly.The shaft temperature on the needle reached -46 degree c, pointing to insufficient thermal insulation of the needle.The device was disassembled, and the vacuum insulation sleeve was tested.Frost formed on the entirety of the vacuum insulation sleeve.Microscopic analysis found damage to the vacuum insulation tube.
Event or Problem Description
It was reported that frost occurred on the needle shaft.An icepearl 2.1 cx 90 degree needle was selected for a renal cryoablation procedure.During the procedure at 2 minutes, it was noticed that the exposed portion of one needle was frosting.The remaining two needles were satisfactory.The affected needle stopped and ablation was completed with the remaining two icepearl needles.All three probes passed the leakage test prior to insertion in the patient.An observation of the skin entry point revealed no injury.There were no patient complications and the patients status was stable.It was further reported that the patient's skin was protected with sterile ultrasound jelly.

• 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): GALIL ISRAEL; tavor bldg 1; yokneam 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14806705
• Report Number: 2134265-2022-06866
• Device Sequence Number: 11931634
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2022

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: 03/29/2023
• Device Model Number: FPRPR3601
• Device Catalogue Number: FPRPR3601
• Device Lot Number: U2499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 07/12/2022; 07/26/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 07/22/2022; 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown