ICEFORCE 2.1 CX 90? CRYOABLATION NEEDLE FPRPR3602

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-28 for ICEFORCE 2.1 CX 90? CRYOABLATION NEEDLE FPRPR3602 manufactured by Galil Medical Ltd.

Event Text Entries

[183174830] Two cryoablation needles were used in a renal cryoablation case. Both needles passed testing, with no failures detected. Within a few minutes of the first freeze, both needles began to frost on the needle shaft. In order to prevent the frost from reaching the patients skin, the physician filled a sterile glove with saline and a hot pack and placed it on the patient's skin for protection. The first thaw cycle of the procedure was passive, and the second thaw cycle of the procedure was active thaw (ithaw). During active thaw, the patient immediately started having muscle twitches. The ithaw was turned on and off each needle to isolate the needle causing the muscle spasm. Passive thaw was used for the defective needle, and active thaw was used for the other needle. The post-procedural scan of the patient looked normal, and the case was completed with no reported injury to the patient. Both needles will be returned to the manufacturer for investigation. This mdr is being submitted for the first needle where only the frost formation on the needle shaft was observed. Please see mdr # 9616793-2020-00048 for the needle that had both frost formation on the needle shaft and electrical stimulation malfunctions.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616793-2020-00047
MDR Report Key9772207
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-28
Date of Report2020-02-28
Date of Event2020-01-29
Date Mfgr Received2020-01-29
Date Added to Maude2020-02-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. SANDRA BAUSBACK-ABALLO
Manufacturer Street300 CONSHOHOCKEN STATE RD 300 FOUR FALLS CORPORATE CTR
Manufacturer CityWEST CONSHOHOCKEN, PA
Manufacturer CountryUS
Manufacturer Phone3311537
Manufacturer G1GALIL MEDICAL LTD.
Manufacturer Street1 TAVOR BUILDING PO BOX 224, INDUSTRIAL PARK
Manufacturer CityYOKNEAM, 2069203
Manufacturer CountryIS
Manufacturer Postal Code2069203
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameICEFORCE 2.1 CX 90? CRYOABLATION NEEDLE
Generic NameCRYOABLATION NEEDLE
Product CodeGEH
Date Received2020-02-28
Model NumberFPRPR3602
Catalog NumberFPRPR3602
Lot NumberT0148
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerGALIL MEDICAL LTD
Manufacturer Address1 TAVOR BUILDING P.O. BOX 224, INDUSTRIAL PARK YOKNEAM, 2069203 IS 2069203


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-28

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