MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LEVEEN? COACCESS?; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	M001262220
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient burn occurred.A 3cm x 15cm leveen coaccess needle electrode system was selected for use in radiofrequency ablation (rfa) procedure to treat a liver tumor.The needle was inserted percutaneously through the patient's abdomen and positioned into the liver tumor.About 5mins into the rfa, the surgeon activated the leveen needle, which resulted in an unknown error message.The procedure had to restart.About 3mins into the second round of rfa, a burn mark was observed at the puncture point of the leveen needle.The procedure was stopped, and the leveen needle was removed.It was then observed that the leveen needle was used without the coaccess cannula.Using ultrasound, it was determined that the target area of the rfa was not satisfactory, and it was decided to continue with another round of rfa.For this additional rfa treatment, the coaccess cannula was used together with the leveen needle.The additional rfa treatment went smoothly.After removing the leveen coaccess system, the puncture point was checked, and it was determined that the burnt skin/tissue had to be removed.A small portion of about 10-15mm in width and about 5mm in depth of the burnt puncture site was excised.The procedure was successfully completed using original method and device.
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned for analysis.No visual damages or defects were observed on the device.An electrical evaluation was performed by measuring the continuity, and the electrode was able to conduct current indicating proper connectivity.A resistance test was performed, and the needle was within specification.Based on the evidence, the reported error message could not be confirmed since no damages or issues were discovered during product inspection.
Event or Problem Description
It was reported that a patient burn occurred.A 3cm x 15cm leveen coaccess needle electrode system was selected for use in radiofrequency ablation (rfa) procedure to treat a liver tumor.The needle was inserted percutaneously through the patient's abdomen and positioned into the liver tumor.About 5mins into the rfa, the surgeon activated the leveen needle, which resulted in an unknown error message.The procedure had to restart.About 3mins into the second round of rfa, a burn mark was observed at the puncture point of the leveen needle.The procedure was stopped, and the leveen needle was removed.It was then observed that the leveen needle was used without the coaccess cannula.Using ultrasound, it was determined that the target area of the rfa was not satisfactory, and it was decided to continue with another round of rfa.For this additional rfa treatment, the coaccess cannula was used together with the leveen needle.The additional rfa treatment went smoothly.After removing the leveen coaccess system, the puncture point was checked, and it was determined that the burnt skin/tissue had to be removed.A small portion of about 10-15mm in width and about 5mm in depth of the burnt puncture site was excised.The procedure was successfully completed using original method and device.
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned for analysis.No visual damages or defects were observed on the device.An electrical evaluation was performed by measuring the continuity, and the electrode was able to conduct current indicating proper connectivity.A resistance test was performed, and the needle was within specification.Based on the evidence, the reported error message could not be confirmed since no damages or issues were discovered during product inspection.
Event or Problem Description
It was reported that a patient burn occurred.A 3cm x 15cm leveen coaccess needle electrode system was selected for use in radiofrequency ablation (rfa) procedure to treat a liver tumor.The needle was inserted percutaneously through the patient's abdomen and positioned into the liver tumor.About 5mins into the rfa, the surgeon activated the leveen needle, which resulted in an unknown error message.The procedure had to restart.About 3mins into the second round of rfa, a burn mark was observed at the puncture point of the leveen needle.The procedure was stopped, and the leveen needle was removed.It was then observed that the leveen needle was used without the coaccess cannula.Using ultrasound, it was determined that the target area of the rfa was not satisfactory, and it was decided to continue with another round of rfa.For this additional rfa treatment, the coaccess cannula was used together with the leveen needle.The additional rfa treatment went smoothly.After removing the leveen coaccess system, the puncture point was checked, and it was determined that the burnt skin/tissue had to be removed.A small portion of about 10-15mm in width and about 5mm in depth of the burnt puncture site was excised.The procedure was successfully completed using original method and device.It was further reported that the patient is all well after two months post operation.The patient is back to the normal daily routine, and all is well.

• Brand Name: LEVEEN? COACCESS?
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20924559
• Report Number: 2124215-2024-78486
• Device Sequence Number: 12035318
• Product Code: GEI
• UDI-Device Identifier: 08714729454922
• UDI-Public: (01)08714729454922(17)261116(10)32878502
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K140495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001262220
• Device Catalogue Number: M001262220
• Device Lot Number: 0032878502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 01/14/2025; 03/10/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 02/07/2025; 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown