MAUDE Adverse Event Report: GALIL MEDICAL LTD. SEEDNET GOLD MRI CRYOABLATION SYSTEM; CRYOSURGICAL DEVICE AND ACESSORIES

Model Number FPRPR2033

Device Problems Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2016

Event Type  malfunction  

Manufacturer Narrative

A service visit was made by a galil medical service engineer.Upon inspection, the service engineer noted that the argon shut-off valve was in the closed position.The valve was opened and the system was tested and passed all testing.Opening the argon shut-off valve corrected the reported problem of no argon gas flowing and thus no iceball formation.The preliminary cause of the event was estimated to be due to user error.The needles are being returned and will be investigated upon receipt.A follow-up report will be filed upon completion of the needle investigation.

Event Description

A seednet gold mri system and needles were tested prior to a cryoablation procedure with no issues.It was reported that during the 1st freeze cycle there was no gas flowing to create a normal iceball although pressures were displayed correctly.The thaw cycle worked normally.The user tried two different needles and ports 2,3, and 4 in the connection panel with no gas flowing or ice ball growing.The procedure was cancelled and will be rescheduled.Three needles will be returned for investigation.

Manufacturer Narrative

A service visit was made by a galil medical service engineer.Upon inspection, the service engineer noted that the argon shut-off valve was in the closed position.The valve was opened and the system was tested and passed all testing.Opening the argon shut-off valve corrected the reported problem of no argon gas flowing and thus no iceball formation.The preliminary cause of the event was estimated to be due to user error.The needles are being returned and will be investigated upon receipt.A follow-up report will be filed upon completion of the needle investigation.Update: the needle was returned for investigation.The manufacturing records were reviewed and no deviations or concerns were noted.The needle passed all investigative tests.The root cause of this event was determined to be user error.

Event Description

A seednet gold mri system and needles were tested prior to a cryoablation procedure with no issues.It was reported that during the 1st freeze cycle there was no gas flowing to create a normal iceball although pressures were displayed correctly.The thaw cycle worked normally.The user tried two different needles and ports 2,3, and 4 in the connection panel with no gas flowing or ice ball growing.The procedure was cancelled and will be rescheduled.Three needles will be returned for investigation.

• Brand Name: SEEDNET GOLD MRI CRYOABLATION SYSTEM
• Type of Device: CRYOSURGICAL DEVICE AND ACESSORIES
• Manufacturer (Section D): GALIL MEDICAL LTD.; 1 tavor building, po box 224; industrial park; yokneam, 20692 03; IS 2069203
• Manufacturer (Section G): GALIL MEDICAL LTD.; 1 tavor building, po box 224; industrial park; yokneam, 20692 03; IS 2069203
• Manufacturer Contact: amy mckinney ; 1 tavor building, po box 224; industrial park; yokneam, 20692 ; IS 20692 ; 2875096
• MDR Report Key: 6048093
• MDR Text Key: 58135759
• Report Number: 9616793-2016-00030
• Device Sequence Number: 1
• Product Code: GEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FPRPR2033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1