MAUDE Adverse Event Report: GALIL MEDICAL LTD ICESPHERE 1.5 90 CRYOABLATION NEEDLE

Model Number	FPRPR3560
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a renal cryoablation procedure, the doctor noticed that insulation on an icesphere failed.The patient's skin was covered with gel to prevent any injury.There was no patient injury reported.
Additional Manufacturer Narrative
The needle was returned for investigation.The manufacturing records were reviewed and no related deviation or concerns were found.The reported frost on the needle shaft was confirmed as the needle failed investigative testing.The needle was disassembled and inspected.No visible soldering gaps or voids were found.Microscopic inspection of the vacuum sleeve was conducted and soldering flux residuals were identified on the external surface of the vacuum sleeve.A bubble test of the vacuum sleeve was conducted and no leak was identified.Based on the investigation results, the customer complaint was verified and the root cause was determined to be a component failure.No relationship was identified between the needle assembly processes and the vacuum loss phenomena.The treatment was completed with no injury to the patient as the physician used gel to protect the patient's skin.

• Brand Name: ICESPHERE 1.5 90 CRYOABLATION NEEDLE
• Common Device Name: CRYOABLATION NEEDLE
• Manufacturer (Section D): GALIL MEDICAL LTD; 1 tavor building, p.o. box 224; industrial park; yokneam,, israel 20692 ; IS 20692
• MDR Report Key: 6723828
• Report Number: 9616793-2017-00073
• Device Sequence Number: 1539423
• Product Code: GEH
• UDI-Device Identifier: 07290104830945
• UDI-Public: 07290104830945
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K152133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2017

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: Physician
• Device Expiration Date: 04/29/2017
• Device Model Number: FPRPR3560
• Device Lot Number: B8745-009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1