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,distri report with the FDA on 2020-02-29 for ICEFORCE 2.1 CX 90? CRYOABLATION NEEDLE FPRPR3602 manufactured by Galil Medical Ltd.

Event Text Entries

[183174585] Three needles were used during a renal cryoablation case. The patient was under conscious sedation during the procedure. A small muscle spasm was observed during the first freeze cycle of the cryoablation procedure. The user continued with the case as planned. A large muscle spasm was observed during the first active thaw cycle. The user stopped the procedure, and identified the faulty needles by turning active thaw on and off sequentially on each needle. The users identified that needles 1 and 3 were causing the muscle spasm. The user decided to only use active thaw on needle 2. During the last freeze cycle, a small spasm was observed again. The active thaw on needle 2 failed during the final active thaw cycle, so passive thaw was used on needle 2 as well. The case was completed with no reported injury to the patient. All 3 needles will be returned to the manufacturer for investigation. This mdr is to report the electrical malfunction for needle 1. Please see the following mdr's for the other needles used during this cryoablation procedure: mdr # 9616793-2020-00043 - needle 2, mdr # 9616793-2020-00044 - needle 3.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616793-2020-00042
MDR Report Key9772482
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-02-29
Date of Report2020-02-29
Date of Event2020-01-16
Date Mfgr Received2020-01-30
Date Added to Maude2020-02-29
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 Received2020-02-29
Model NumberFPRPR3602
Catalog NumberFPRPR3602
Lot NumberT0225
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 2020-02-29

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