ICEROD 90 MRI NEEDLE / MRI SE FPRPR3195

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 2020-02-27 for ICEROD 90 MRI NEEDLE / MRI SE FPRPR3195 manufactured by Galil Medical Ltd..

Event Text Entries

[182744733] Needle 2 was returned to the manufacturer for investigation. The needle's atp and iceball formation properties were found within specification, and the reported complaint could not be confirmed from the needle investigation.
Patient Sequence No: 1, Text Type: N, H10


[182744734] 4 needles were used in a mri guided renal cryoablation procedure. During the case, all 4 icerod mri needles only reached an iceball size of approx. 1 cm, which was insufficient for the procedure. Extra active thawing cycles did not resolve this. Multiple freezing cycles were conducted in an attempt to reach an acceptable ablation zone. The treatment was deemed unsuccessful, and a new cryoablation procedure has been scheduled for this patient. All four needles were returned to the manufacturer for investigation, and the cryoablation system was investigated in a field service call. This mdr summarises the investigation results of the second needle used in this complaint. Please see the following mdr's for the other devices used during this cryoablation procedure: 3004462490-2020-00001 - cryoablation system, 9616793-2020-00035 - needle 1, 9616793-2020-00037 - needle 3, 9616793-2020-00038 - needle 4.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616793-2020-00036
MDR Report Key9767059
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-02-27
Date of Report2020-02-27
Date of Event2020-01-28
Date Mfgr Received2020-01-28
Date Added to Maude2020-02-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 NameICEROD 90 MRI NEEDLE / MRI SE
Generic NameCRYOSURGICAL DEVICES AND ACCESSORIES
Product CodeGEH
Date Received2020-02-27
Returned To Mfg2020-02-13
Model NumberFPRPR3195
Catalog NumberFPRPR3195
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
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 2020-02-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.