MAUDE Adverse Event Report: BTG YOKNEAM ICESEED 90 DEGREE NEEDLE; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number FPRPR3202

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

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 03/05/2024

Event Type  Injury  

Manufacturer Narrative

B3: approximated based on the date the manufacturer became aware of the event.

Event Description

It was reported that a severe thermal burn occurred, requiring medical intervention.An iceseed 90 degree needle was selected for cryoneurolysis of a post-amputee neuroma proximal to the skin.At the time of the procedure, there were no complications, and no abnormal frost was observed on the needle.The skin was protected with a glove filled with warm saline and a heat pack following the procedure.However, at an emergent follow-up, the appearance of black skin at the ablation zone was observed.The thermal injury is being treated by the vascular wound care team.

• Brand Name: ICESEED 90 DEGREE NEEDLE
• 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): GALIL ISRAEL; tavor bldg 1; yoenaem 20692 03; IS 2069203
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18989057
• MDR Text Key: 338736775
• Report Number: 2124215-2024-18262
• Device Sequence Number: 1
• Product Code: GEH
• UDI-Device Identifier: 07290104830235
• UDI-Public: 07290104830235
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K003065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: FPRPR3202
• Device Catalogue Number: FPRPR3202
• Device Lot Number: U2687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention