MAUDE Adverse Event Report: GALIL MEDICAL LTD ICEROD 1.5 MM 90 DEGREE MRI NEEDLE / MRI SE; CRYOABLATION NEEDLE, PRODUCT CODE

Model Number	FPRPR3195
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	02/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned and could not be investigated.The physician was unaware that the mri needles possess air-gap insulation and, therefore, not insulated.Vacuum sleeve failure is a known potential malfunction.The risk to the patient is the potential for a skin burn due to frost on the needle shaft.Galil medical's labeling includes precautions instructing users to protect the skin with warm saline, when appropriate.The case was completed with the patient experiencing superficial lesion.If additional information becomes available a followup report will be filed.
Event or Problem Description
It was reported that during a mri procedure there was observation of a skin burn due to an apparent procedural issue.During follow-up, the doctor confirmed that he does not use any form of external/topical skin protection as a standard of practice.He stated that they had a glove filled with warm saline as well as a continuous flow of warm saline that was run over the needle insertion sites.The tumor was superficial (appx 2cm below the skin).7 icerod needles were placed at fairly steep angles in alternating opposing directions to allow for tumor coverage at a more superficial angle.Based on the imaging, the frost bite was from the shaft contacting the skin.It is unknown if any treatment was performed.

• Brand Name: ICEROD 1.5 MM 90 DEGREE MRI NEEDLE / MRI SE
• Common Device Name: CRYOABLATION NEEDLE, PRODUCT CODE
• Manufacturer (Section D): GALIL MEDICAL LTD; 1 tavor building, p.o. box 224; industrial park; yokneam, israel 20692 03; IS 2069203
• MDR Report Key: 8426629
• Report Number: 9616793-2019-00017
• Device Sequence Number: 14015584
• Product Code: GEH
• UDI-Device Identifier: 07290104830297
• UDI-Public: 07290104830297
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2019

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 Model Number: FPRPR3195
• Device Catalogue Number: FPRPR3195
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 03/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other