MAUDE Adverse Event Report: BTG YOKNEAM ICESPHERE 1.5 CX 90 DEGREE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3573
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a needle shaft leak occurred.An icesphere 1.5 cx 90 degree needle was selected for a cryoablation procedure to treat a desmoid tumor.During the test phase, however, there were bubbles seen coming from the needle shaft while it was fully submerged in the saline bath.There was no visible damage seen.The needle was exchanged another of the same model.The procedure was completed successfully with the new needle and there were no patient complications.
Event or Problem Description
It was reported that a needle shaft leak occurred.An icesphere 1.5 cx 90 degree needle was selected for a cryoablation procedure to treat a desmoid tumor.During the test phase, however, there were bubbles seen coming from the needle shaft while it was fully submerged in the saline bath.There was no visible damage seen.The needle was exchanged another of the same model.The procedure was completed successfully with the new needle and there were no patient complications.
Additional Manufacturer Narrative
Device evaluation by manufacturer: an icesphere 1.5 cx 90 degree was returned to arden hills cis for analysis.Visual inspection was completed with no problems detected.The needle was connected to the icefx console, and a two-minute confidence test was performed.During the pretest there were bubbles seen coming out of the needle at the shaft-joint area.The exterior sheath was removed to be able to see the shaft-joint area more closely to visually inspect the glue.While doing so, it was observed that there were irregularities in the glue.The needle was placed back in the bath to verify the leak.The bubbles were confirmed.

• Brand Name: ICESPHERE 1.5 CX 90 DEGREE
• 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; yokneam 20692 03; IS 2069203
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18144846
• Report Number: 2124215-2023-61712
• Device Sequence Number: 20708681
• Product Code: GEH
• UDI-Device Identifier: 07290104831133
• UDI-Public: 07290104831133
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

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: 10/14/2024
• Device Model Number: FPRPR3573
• Device Catalogue Number: FPRPR3573
• Device Lot Number: 0030421040
• 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: 10/26/2023
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown