MAUDE Adverse Event Report: GALIL MEDICAL LTD ICESPHERE¿ 1.5 CX 90° CRYOABLATION NEEDLE

Model Number	FPRPR3573
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Spinal Cord Injury (2432); Paraplegia (2448)
Date of Event	01/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Two cryoablation needles were used to treat a sclerotic metastatic thoracic vertebral body using bipedicular access.After the procedure, a thermal lesion to the spinal cord was discovered.The patient is paraplegic as a result of the lesion.The user believes the thermal lesion to be related to the cryoablation procedure.There was no reported malfunction with the cryoablation needles, and the needles will not be returned to the manufacturer for investigation.An anonymised transverse image of the needle placement was sent by the user to the manufacturer to estimate the expected posterior limit of the iceball.This mdr is being submitted for the first needle used during this procedure.Please see mdr # 9616793-2020-00046 for the second needle used during this procedure.
Additional Manufacturer Narrative
Medical assessment and review of the iceball dimensions during the procedure confirmed that the thermal lesion was directly related to the procedure.There was no indication of a device malfunction.Adjacent organ injury is a known risk with cryoablation, and is listed as a potential adverse event in the needle ifu.
Event or Problem Description
This mdr is to document the follow-up and medical assessment performed by the manufacturer for the thermal lesion of the spinal cord that was initially reported.Further investigation or follow-up is not planned for this complaint.This mdr is being submitted for the first needle used during this procedure.Please see mdr # 9616793-2020-00046 for the second needle used during this procedure.

• Brand Name: ICESPHERE¿ 1.5 CX 90° CRYOABLATION NEEDLE
• Common Device Name: CRYOABLATION NEEDLE
• Manufacturer (Section D): GALIL MEDICAL LTD; 1 tavor building; p.o. box 224, industrial park; yokneam, 20692 03,; IS 2069203,
• MDR Report Key: 9772515
• Report Number: 9616793-2020-00045
• Device Sequence Number: 19476418
• Product Code: GEH
• UDI-Device Identifier: 07290104831133
• UDI-Public: 07290104831133
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K181741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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 Expiration Date: 03/22/2021
• Device Model Number: FPRPR3573
• Device Catalogue Number: FPRPR3573
• Device Lot Number: A1974
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 02/29/2020
• Supplement Report FDA Received Date: 04/15/2020
• 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: Life Threatening; Required Intervention