MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION / GALIL MEDICAL LTD. GALIL ICEFORCETM 2.1 CX 90DEG CRYOABLATION NEEDLE ; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number ICEFORCETM 2.1 CX 90DEG

Device Problems Crack (1135); Gas/Air Leak (2946)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 05/11/2020

Event Type  Injury  

Event Description

A galil iceforcetm 2.1 cx 90 degree cryoablation needle was successfully connected to galil's visualicetm cryoablation system and passed the vendor integrity test; 5 other probes of the same model were connected to the system during this procedure.Two freezing cycles of 8 and 6 minutes, respectively, were successfully performed with good ice formation.The two cycles were interspersed by a passive thaw cycle.Subsequently, a 10 minute-cycle of active, resistive thaw (i-thaw) was performed.At the end of that cycle, ct imaging revealed substantial amount of retroperitoneal and venous gas.Additionally, a moderate skin burn was observed at the insertion point of one needle.The patient was immediately placed with the head down and a head ct was obtained which was negative for intracranial air.The patient was carefully woken up with expert anesthesia care and no neurologic deficit was noted.After the probes were extracted from the patient, a leak along the shaft of the same needle that caused the skin burn appeared when the probe was inserted in its testing environment and either freeze, thaw or i-thaw was activated.The leakage originate at the distal end of the shaft, at the junction with the trocar.Microct and optical microscopy both revealed a rupture point at the location where the leak appeared.Fda safety report id# (b)(4).

• Brand Name: GALIL ICEFORCETM 2.1 CX 90DEG CRYOABLATION NEEDLE
• Type of Device: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION / GALIL MEDICAL LTD. ; marlborough MA 01752 1234
• MDR Report Key: 10074434
• MDR Text Key: 191616043
• Report Number: MW5094553
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ICEFORCETM 2.1 CX 90DEG
• Device Lot Number: T0729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 42 YR