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

Model Number	M001262270
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	11/11/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that an intrauterine fetal death occurred.A 2.0cm x 25cm leveen superslim needle electrode was selected for use with an rf 3000 generator.Radiofrequency ablation (rfa) was performed in a twin reversed arterial perfusion (trap) procedure.The procedure was successfully completed under ultrasound, and after 25 cumulative minutes, there was roll off with an impedance of 270ohm.Procedurally, the physician deemed the case a success.There were no device issues.Everything procedurally was as expected.However, a slightly decreased heartbeat of the pump twin (intended surviving twin) was noted by the end of the procedure.The decreased heartbeat was a consequence of hemodynamic changes in response to rfa.It was reported that the possibility of this occurring was discussed with the patient.Subsequently, the pump twin was unwell to the point of being non-viable/deceased.The mother was well.
Additional Manufacturer Narrative
Correction to h6: evaluation conclusion codes.
Event or Problem Description
It was reported that an intrauterine fetal death occurred.A 2.0cm x 25cm leveen superslim needle electrode was selected for use with an rf 3000 generator.Radiofrequency ablation (rfa) was performed in a twin reversed arterial perfusion (trap) procedure.The procedure was successfully completed under ultrasound, and after 25 cumulative minutes, there was roll off with an impedance of 270ohm.Procedurally, the physician deemed the case a success.There were no device issues.Everything procedurally was as expected.However, a slightly decreased heartbeat of the pump twin (intended surviving twin) was noted by the end of the procedure.The decreased heartbeat was a consequence of hemodynamic changes in response to rfa.It was reported that the possibility of this occurring was discussed with the patient.Subsequently, the pump twin was unwell to the point of being non-viable/deceased.The mother was well.

• Brand Name: LEVEEN SUPERSLIM
• 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: 20844967
• Report Number: 2124215-2024-76183
• Device Sequence Number: 12772595
• Product Code: GEI
• UDI-Device Identifier: 08714729441700
• UDI-Public: 08714729441700
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113090
• 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
• Report Date (Section B): 07/09/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: M001262270
• Device Catalogue Number: M001262270
• Device Lot Number: 0032698012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 07/09/2025
• Date Device Manufactured: 10/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown