MAUDE Adverse Event Report: BTG YOKNEAM ICEROD CX 90 DEGREE NEEDLE/VL; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number FPRPR3533

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 15dec2023.The icerod cx 90 degree needle was returned without an associated complaint.However, device analysis revealed frost on the needle shaft.

Manufacturer Narrative

Device evaluation by manufacturer: visual inspection of the exterior of the needle showed no abnormalities.The needle was connected to the icefx console, and a two-minute confidence test was performed, and no abnormalities were noticed.A five-minute freeze cycle was performed, and it was found that the needle shaft became completely covered in frost.The needle was disassembled, and the vacuum sleeve was tested for vacuum integrity.The vacuum sleeve became covered in frost, meaning the vacuum sleeve was defective.The vacuum sleeve was inspected under a microscope, and it was found that the vacuum sleeve had abnormalities in the metal that likely led to the vacuum integrity failing.It was also noted that even though the needle shaft was straight, the vacuum sleeve was bent.

• Brand Name: ICEROD CX 90 DEGREE NEEDLE/VL
• Type of Device: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; tavor building number 1; yokneam 20692 03; IS 2069203
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18376951
• MDR Text Key: 331385024
• Report Number: 2124215-2023-72517
• Device Sequence Number: 1
• Product Code: GEH
• UDI-Device Identifier: 07290104830587
• UDI-Public: 07290104830587
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K121251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FPRPR3533
• Device Catalogue Number: FPRPR3533
• Device Lot Number: 0029757955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2023
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1