MAUDE Adverse Event Report: GALIL MEDICAL LTD ICEFORCE 2.1 CX 90° CRYOABLATION NEEDLE

Model Number FPRPR3602

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Muscle Spasm(s) (1966)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

The needle was returned to the manufacturer for investigation.The needle's electrical parameters were found within specification, and the needle was operated several times in thaw mode with no issues.The reported complaint could not be confirmed.The needle lot manufacturing records were reviewed, and 4 electrical malfunctions were recorded within the needle batch.

Event Description

Two needles were used in a cryoablation procedure.Both needles did not active thaw (ithaw).One of the needles also caused muscle spasms, but the user was unsure which needle caused the spasm.The case was completed with no reported injury to the patient.This mdr is being filed for the first needle used for the cryoablation procedure.Please see mdr # 9616793-2020-00052 for the second needle used in this cryoablation procedure.

• Brand Name: ICEFORCE 2.1 CX 90° CRYOABLATION NEEDLE
• Type of Device: CRYOABLATION NEEDLE
• Manufacturer (Section D): GALIL MEDICAL LTD; 1 tavor building; p.o. box 224, industrial park; yokneam, 20692 03; IS 2069203
• Manufacturer (Section G): GALIL MEDICAL LTD.; 1 tavor building; po box 224, industrial park; yokneam, 20692 03; IS 2069203
• Manufacturer Contact: sandra bausback-aballo ; 300 conshohocken state rd; 300 four falls corporate ctr; west conshohocken, pa ; 3311537
• MDR Report Key: 9772615
• MDR Text Key: 182564513
• Report Number: 9616793-2020-00051
• Device Sequence Number: 1
• Product Code: GEH
• UDI-Device Identifier: 07290104831003
• UDI-Public: 07290104831003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2021
• Device Model Number: FPRPR3602
• Device Catalogue Number: FPRPR3602
• Device Lot Number: T0120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1