MAUDE Adverse Event Report: BTG YOKNEAM ICESPHERE S 90 DEGREE NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3561
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that pneumatosis occurred after use of the cryoablation needle.An icesphere s 90 degree needle was selected for a cryoablation procedure to treat a kidney lesion.The probe was tested.It was reported that no gas leaks were seen, and the ice ball was visualized; however, there was one small bubble seen, but no stream of bubbles.The physician inspected the needle and determined that it looked fine, so the needle was used.The probe was inserted into the patient through the posterior back muscle, and it could not be visualized on the screen, so it was locked into the channel again and prompted to re-test it.This time, the probe was tested inside the patient.The first freeze was completed with no issue.At the end of the second freeze, however, after 10 minutes, the ct image showed air in the subcutaneous muscle.The needle was removed and re-tested in saline.Small bubbles were seen from where the needle meets the handle.After pressing the freeze function while in the saline, multiple gas bubbles were present.The needle had been completed successfully with the original device.The patient was in stable condition after the procedure, and no intervention was needed.
Event or Problem Description
It was reported that pneumatosis occurred after use of the cryoablation needle.An icesphere s 90 degree needle was selected for a cryoablation procedure to treat a kidney lesion.The probe was tested.It was reported that no gas leaks were seen, and the ice ball was visualized; however, there was one small bubble seen, but no stream of bubbles.The physician inspected the needle and determined that it looked fine, so the needle was used.The probe was inserted into the patient through the posterior back muscle, and it could not be visualized on the screen, so it was locked into the channel again and prompted to re-test it.This time, the probe was tested inside the patient.The first freeze was completed with no issue.At the end of the second freeze, however, after 10 minutes, the ct image showed air in the subcutaneous muscle.The needle was removed and re-tested in saline.Small bubbles were seen from where the needle meets the handle.After pressing the freeze function while in the saline, multiple gas bubbles were present.The needle had been completed successfully with the original device.The patient was in stable condition after the procedure, and no intervention was needed.
Additional Manufacturer Narrative
Device evaluated by manufacturer: an icesphere s 90 degree needle lot (31084115) was returned to arden hill 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 needle had the exterior sheath removed to be able to see the shaft-joint area more closely to visually inspect the glue.While doing so pictures were capture of irregularities in the glue, there was a gap between the shaft and needle where the glue should be in place.The needle was placed back in the bath to verify the leak.The bubbles were confirmed to be coming from that upper left region where the glue gap was captured.It was also found that there was blood found under the handle heat shrink commonly seen when the handle is pressed into the skin.No further testing was needed.

• Brand Name: ICESPHERE S 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; yokneam 20692 03; IS 2069203
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17201669
• Report Number: 2124215-2023-32686
• Device Sequence Number: 12436196
• Product Code: GEH
• UDI-Device Identifier: 07290104830556
• UDI-Public: 07290104830556
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141485
• 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): 08/08/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2025
• Device Model Number: FPRPR3561
• Device Catalogue Number: FPRPR3561
• Device Lot Number: 0031084115
• 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: 05/31/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male