MAUDE Adverse Event Report: BTG GALIL MEDICAL ICEROD PLUS 90 DEGREE NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR3508
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported material separation occurred.A renal cryoablation procedure was performed in the kidney, using two icerod plus cryoablation needles.The procedure itself was completed without any problem, however, a white spot was observed when the computed tomography (ct) scan was taken after the removal of the needle, indicating that something might have been left inside the body.A ct scan was performed again after a few hours and showed nothing unusual.The needles were visibly reviewed and no defects on the needles were apparent.No additional intervention was performed.No further patient complications were reported.
Event or Problem Description
It was reported material separation occurred.A renal cryoablation procedure was performed in the kidney, using two icerod plus cryoablation needles.The procedure itself was completed without any problem, however, a white spot was observed when the computed tomography (ct) scan was taken after the removal of the needle, indicating that something might have been left inside the body.A ct scan was performed again after a few hours and showed nothing unusual.The needles were visibly reviewed and no defects on the needles were apparent.No additional intervention was performed.No further patient complications were reported.
Additional Manufacturer Narrative
Device analysis: the device was returned and thoroughly tested for any evidence of material separation from the needle that could have been left in the patient after treatment.Visual investigation showed no evidence of any material separation.A leak test was performed and there was evidence of a gas leak at the handle shaft.Disassembly revealed a lack of glue found in the connection of the needle handle to the shaft.The account reported that after a cryo procedure they noticed something on the ct scan that appeared to be material left in the patient from the needle.Investigation found no evidence of material separation from the needle that could have contributed to the complaint.Further investigation found a leak from the needle shaft handle.Disassembly of the needle found a lack of glue at the shaft handle.The complaint conclusion code is manufacturing deficiencies; a lack of glue at the needle to handle shaft caused a return gas leak on a portion of the device outside of the patient.

• Brand Name: ICEROD PLUS 90 DEGREE NEEDLE
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG GALIL MEDICAL; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): BTG GALIL MEDICAL; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12926283
• Report Number: 2134265-2021-15017
• Device Sequence Number: 5647760
• Product Code: GEH
• UDI-Device Identifier: 07290104830563
• UDI-Public: 07290104830563
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110946
• 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
• Report Date (Section B): 02/21/2022

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: 01/11/2023
• Device Model Number: FPRPR3508
• Device Catalogue Number: FPRPR3508
• Device Lot Number: U1983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown