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

Model Number	M001262240
Medical Device Problem Codes	Difficult to Insert (1316); Retraction Problem (1536)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a burn.A leveen? coaccess needle was selected for use.After ablation was completed, there was difficulty reinserting the needle into its sheath to remove it from the patient.After the needle was removed, there was a second or third degree burn observed surrounding the puncture site.The physician consulted with the dermatology team to obtain instructions on how best to proceed.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the patient experienced a burn.A leveen? coaccess needle was selected for use.After ablation was completed, there was difficulty reinserting the needle into its sheath to remove it from the patient.After the needle was removed, there was a second or third degree burn observed surrounding the puncture site.The physician consulted with the dermatology team to obtain instructions on how best to proceed.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Updated fields: h6 - device codes: updated to retraction problem to more accurately reflect the reported event.Investigation results: device history record (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the leveen? coaccess? device confirmed that the events of "retraction problem" and "burn(s)" are known events defined in the product's risk management documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of "unable to exclude device problem".

• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 24500182
• Report Number: 2124215-2026-11751
• Device Sequence Number: 9870116
• Product Code: GEI
• UDI-Device Identifier: 08714729454939
• UDI-Public: (01)08714729454939(17)260612(10)31808354
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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 Expiration Date: 06/12/2026
• Device Model Number: M001262240
• Device Catalogue Number: M001262240
• Device Lot Number: 0031808354
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/01/2026
• Date Device Manufactured: 06/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown