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 Hemorrhage/Bleeding (1888)

Event Date 08/31/2023

Event Type  Injury  

Event Description

It was reported that a hemorrhage occurred.An icerod cx 90 degree needle/vl was used to treat two liver masses.After successful treatment, at the end of the final thaw, cautery was performed by the needles.Each needle was cauterized for 30 seconds and was pulled back 29mm, then another 30 seconds cautery, and so on until the needle track within the liver was completely cauterized.No initial complications were seen.The needles were disconnected and disposed of, and the patient was bandaged.Post-needle-removal scan was scanned and showed that within one of the needle track remnants, there appeared to be a small active bleed.It was scanned several more times to see progression, and the physician decided to take the patient to the interventional radiologist to do an angiogram and see what vessel was causing the bleed.The branch was found and successfully embolized.The patient remained an inpatient for 3 days before recovering and being discharged.

• 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: 18011904
• MDR Text Key: 326620928
• Report Number: 2124215-2023-55115
• Device Sequence Number: 1
• Product Code: GEH
• UDI-Device Identifier: 07290104830587
• UDI-Public: 07290104830587
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FPRPR3533
• Device Catalogue Number: FPRPR3533
• Device Lot Number: 0031525938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization