MAUDE Adverse Event Report: GALIL MEDICAL LTD. ICEROD 90 MRI NEEDLE / MRI SE; CRYOSURGICAL DEVICES AND ACCESSORIES

Model Number	FPRPR3195
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: ICEROD 90 MRI NEEDLE / MRI SE
• Common Device Name: CRYOSURGICAL DEVICES AND ACCESSORIES
• Manufacturer (Section D): GALIL MEDICAL LTD.; 1 tavor building; p.o. box 224, industrial park; yokneam, 20692 03; IS 2069203
• MDR Report Key: 9767059
• Report Number: 9616793-2020-00036
• Device Sequence Number: 2787607
• Product Code: GEH
• UDI-Device Identifier: 07290104830297
• UDI-Public: 07290104830297
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K051052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FPRPR3195
• Device Catalogue Number: FPRPR3195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1