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

Model Number	FPRPR3193
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was identified during a literature review.Hemorrhage is a known risk associated with cryoablation of renal cryoablation and included in the product labeling.Lot numbers were not provided and therefore a lot history record review could not be performed.The devices were not returned and there were no device malfunction reported in the article.
Event or Problem Description
This complaint is derived from a literature publicized in 2018 in the cardiovasc intervent radiol titled "ice ball crack during ct-guided renal cryoablation using 1.5- mm-diameter cryoprobes".The author stated in the discussion section that during their reviews of laparoscopic renal cryoablation, ice ball fractures occurred in 8-17% of cases, some of which requiring blood transfusions or surgical managements.The author explained that when cracks occur in an ice ball, the adjacent renal parenchyma will be also involved in the fracture, and this could lead to massive hemorrhage.

• Brand Name: ICEROD 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: 8341115
• Report Number: 9616793-2019-00008
• Device Sequence Number: 2253874
• Product Code: GEH
• UDI-Device Identifier: 07290104830273
• UDI-Public: 07290104830273
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/14/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: FPRPR3193
• Device Catalogue Number: FPRPR3193
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/14/2019
• 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; Required Intervention