MAUDE Adverse Event Report: GALIL MEDICAL LTD ICESEED MRI NEEDLE / MRI SE; CRYOABLATION NEEDLE

Model Number	FPRPR3192
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	09/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is approximated.The needles were not returned for investigation and the lot numbers remain unknown; therefore an internal investigation could not be performed.No device malfunction was reported in association with the event.This mdr is being reported for the medical and surgical intervention to treat the patient's wound infection and area of necrosis outside the ablation zone.Wound infection and adjacent organ injury are known risks associated with the procedure and addressed in the product user manual and ifu.
Event or Problem Description
It was reported that a patient underwent quadrant prostate mri cryoablation with 6 iceseed needles placed through the prostate grid, 5 mm apart on (b)(6) 2019.Warm saline shower was applied to perineum during the procedure.The physician noted 3 freeze/thaw cycles, with last freeze following withdrawal of one needle to treat the apical region of the prostate.The procedure was completed as planned with no evidence of thermal skin injury at the end of the procedure.In retrospect, the physician notes potential changes around the needle shafts on mri, but at the time challenging to see due to artifact.The patient presented 7-10 days after procedure with perineal wound and infection.Mri showed ablation of the intended prostate region as well as a cone shaped area of necrosis in the peripheral fat extending from the base of the penis up to and including the skin.The patient was admitted, surgery consulted, and iv antibiotics started.Surgery for wound debridement followed by wound pack and outpatient wound care.No device malfunction was reported in association with this event.The needles will not be returned for investigation.

• Brand Name: ICESEED MRI NEEDLE / MRI SE
• Common Device Name: CRYOABLATION NEEDLE
• Manufacturer (Section D): GALIL MEDICAL LTD; 1 tavor building; p.o. box 224; industrial park, 20692 03; IS 2069203
• MDR Report Key: 9205398
• Report Number: 9616793-2019-00071
• Device Sequence Number: 3031291
• Product Code: GEH
• UDI-Device Identifier: 07290104830266
• UDI-Public: 07290104830266
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2019

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: FPRPR3192
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/17/2019
• 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: Required Intervention