MAUDE Adverse Event Report: GALIL MEDICAL LTD ICEROD 90 NEEDLE; CRYOABLATION NEEDLE

Model Number	FPRPR3204
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Peroneal Nerve Palsy (2362)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
These events were identified in a literature review.Damage to adjacent structures is a known potential adverse event.Ablation of a sensory nerve may lead to anesthesia, paresthesia, or dysesthesia, whereas ablation of a motor nerve may lead to paralysis or paresis and is generally more clinically significant.The risk is documented in the needle risk assessment, ifu and user manual.No additional information regarding the second patient was provided.The devices were not returned and no device malfunctions were reported in the article or during follow up with the author.
Event or Problem Description
This report is derived from a literature article publicized in cirse 2019 titled "local control and analgesic efficacy of percutaneous cryoablation for desmoid tumors." percutaneous cryoablation using ct or ultrasound was performed on 41 desmoid tumors in 34 patients between july 2012 and september 2016 using galil medical's visual-ice system and various galil cryoprobes.Patients received clinical and radiological follow-up at 6 months post-procedure, with pain-rating and adverse events being recorded.The article reported that two patients had cirse class grade 4 complications involving palsy of the common fibular nerve.Patients with grade 4 complications are as follows: patient 2 was a (b)(6) year old female who had cryoablation in the right leg using 3 icerod probes.Patient 3 was a (b)(6) year old male who had cryoablation in the right leg using 3 icerod probes.Follow up with the corresponding author was performed where more information was provided regarding patient 3: patient "was treated by cryoablation of a desmoid tumor with ct guidance (popliteal fossa) by another ir.The patient had a palsy of the fibular nerve with complete motor and sensory defect.The patient had high neuropathic pain during one year after the cryoablation and was very disabled.One miraculous day, 20 months after the cryoablation, he had almost complete recovery of the palsy.(18 to 24 months is a common duration for recovery after a nervous lesion according to literature and the experience of the orthopedic and traumatic surgeons in our center).He can now walk, run and do some sport and only have a very little defect of the toe.Patient had later local recurrence and accepted to be treated again with cryoablation because this time i did the cryoablation and i have more skill on ultrasound of peripherical nerves than the previous ir.The cryoablation with us guidance and electrical monitoring of the fibular nerve have permitted to treat the recurrence of the tumor without any further complication." no device malfunctions were reported in the article.

• Brand Name: ICEROD 90 NEEDLE
• 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: 9214001
• Report Number: 9616793-2019-00066
• Device Sequence Number: 19430140
• Product Code: GEH
• UDI-Device Identifier: 07290104830242
• UDI-Public: 07290104830242
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2019

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: FPRPR3204
• Device Catalogue Number: FPRPR3204
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/21/2019
• 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