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

Model Number	FPRPR3601
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two needles of the same lot had leaks discovered during the prep phase.Two icepearl 2.1 cx 90 degree needles from the same batch were selected for treatment of renal cell carcinoma.During the prep/testing phase, while outside the patient, the needles were fully submerged in saline for integrity testing and a gas leak was found near the needle tip of both needles.It was further noted that one of the needles also had a leak at the shaft to needle joint.Two new needles were tested and used to complete the procedure successfully without sequela.
Additional Manufacturer Narrative
Device eval by manufacturer: the complaint device was returned for product analysis.There were no visual deficiencies found with the returned needle.The needle was tested for a gas leak and bubbles were seen from the needle shaft handle joint (no leak was seen from the tip of the needle), and disassembly of the needle found a crack in the glue at the connection of the needle handle to the shaft.
Event or Problem Description
It was reported that two needles of the same lot had leaks discovered during the prep phase.Two icepearl 2.1 cx 90 degree needles from the same batch were selected for treatment of renal cell carcinoma.During the prep/testing phase, while outside the patient, the needles were fully submerged in saline for integrity testing and a gas leak was found near the needle tip of both needles.It was further noted that one of the needles also had a leak at the shaft to needle joint.Two new needles were tested and used to complete the procedure successfully without sequela.

• Brand Name: ICEPEARL 2.1 CX 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 ISRAEL; tavor bldg 1; po box 224; yoenaem 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13938289
• Report Number: 2134265-2022-03452
• Device Sequence Number: 20459316
• Product Code: GEH
• UDI-Device Identifier: 07290104830990
• UDI-Public: 07290104830990
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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: 10/31/2022
• Device Model Number: FPRPR3601
• Device Catalogue Number: FPRPR3601
• Device Lot Number: U1503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Race: White