ICEPEARL 2.1 CX 90? CRYOABLATION NEEDLE FPRPR3601

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 2020-02-29 for ICEPEARL 2.1 CX 90? CRYOABLATION NEEDLE FPRPR3601 manufactured by Galil Medical Ltd..

Event Text Entries

[182551437] One icepearl cx cryoablation needle was used for a left renal lesion (1. 2cm mass). An additional icesphere cx needle was introduced in the third freeze cycle of the procedure. Both needles passed testing, with no leaks, a uniform iceball, with correct formation followed by proper thawing. No error message occured during the needle test. A biopsy was performed prior to freezing, and the needle positioning was confirmed with ct with no critical structures observed near the planned ablation zone. The iceball was not visible throughout the procedure. No fluctuation in needle temperature, freezing percentage and gas pressure was observed throughout the entire procedure. Contrast was produced in the fourth cycle, but no iceball was visible. The user specifically noted that ice was not visible at the following timepoints: first freeze - 5 minutes, first freeze - 8 minutes, second freeze, third freeze, fourth freeze. After the procedure, the needles were then tested by being submerged in basin of water, and tested successfully with ice immediately forming. There was no indication of a freezing error, needle leak or needle clog. The needles were kept and will be returned to the manufacturer for investigation. At the post scan of the procedure, no enhancement or bleeding was observed. The user decided to wait at the follow-up scan to determine if the ablation was successful. The patient has not experienced any complications. This report is being filed conservatively on the premise that the treatment may not have been successful, and a new treatment may have to be planned for this case. This mdr is for the icepearl cx needle that was used during the case. Please refer to mdr # 9616793-2020-00050 for the icesphere cx needle used during this procedure.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9616793-2020-00050
• MDR Report Key: 9772620
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-02-29
• Date of Report: 2020-02-29
• Date of Event: 2020-01-30
• Date Mfgr Received: 2020-01-30
• Date Added to Maude: 2020-02-29
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. SANDRA BAUSBACK-ABALLO
• Manufacturer Street: 300 CONSHOHOCKEN STATE RD, 300 FOUR FALLS CORPORATE CTR.
• Manufacturer City: WEST CONSHOHOCKEN, PA
• Manufacturer Country: US
• Manufacturer Phone: 3311537
• Manufacturer G1: GALIL MEDICAL LTD.
• Manufacturer Street: 1 TAVOR BUILDING PO BOX 224, INDUSTRIAL PARK
• Manufacturer City: YOKNEAM, 2069203
• Manufacturer Country: IS
• Manufacturer Postal Code: 2069203
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ICEPEARL 2.1 CX 90? CRYOABLATION NEEDLE
• Generic Name: CRYOSURGICAL DEVICES AND ACCESSORIES
• Product Code: GEH
• Date Received: 2020-02-29
• Model Number: FPRPR3601
• Catalog Number: FPRPR3601
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GALIL MEDICAL LTD.
• Manufacturer Address: 1 TAVOR BUILDING P.O. BOX 224, INDUSTRIAL PARK YOKNEAM, 2069203 IS 2069203

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-29