MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ISLEEVE 14F; INTRODUCER, CATHETER

Model Number	10445
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that atypical tip damage occurred.During a transcatheter aortic valve replacement (tavr) procedure vascular access was obtained via a mildly calcified and mildly tortuous transfemoral approach.A 14f isleeve introducer sheath was placed and a safari2 guidewire was advanced into position.An accurate prime delivery system with loaded accurate prime valve was advanced and removed through the 14f isleeve introducer sheath with no resistance noted.At the conclusion of the procedure, after removal from the patient, it was observed the radiopaque tip of the 14f isleeve introducer sheath was split in an atypical manner creating a sharp edge.No patient complications were reported.
Event or Problem Description
It was reported that the tip split in a manner creating a sharp edge occurred.During a transcatheter aortic valve replacement (tavr) procedure vascular access was obtained via a mildly calcified and mildly tortuous transfemoral approach.A 14f isleeve introducer sheath was placed and a safari2 guidewire was advanced into position.An acurate prime delivery system with loaded acurate prime valve was advanced and removed through the 14f isleeve introducer sheath with no resistance noted.At the conclusion of the procedure, after removal from the patient, it was observed the radiopaque tip of the 14f isleeve introducer sheath was split in an atypical manner creating a sharp edge.No patient complications were reported.
Additional Manufacturer Narrative
This supplemental report is being submitted with an update to sections: h6 device codes, h6 component codes, h6 evaluation method codes, h6 evaluation result codes, h6 evaluation conclusion codes.Device technical analysis the 14f isleeve introducer sheath was returned and device analysis was performed by a bsc quality technician.The returned device consisted of a 14f isleeve introducer sheath without the dilator.The device was visually and microscopically evaluated.The 14f isleeve introducer sheath was kinked in numerous locations.All three (3) expansion seams were expanded with the tip split at one (1) seam.The expanded seams and tip of the 14f isleeve introducer sheath occurred along the seam line and is expected during use of the device; therefore, this is not considered device damage.The tip was split on both sides of an expansion seam which created a torn flap that was almost detached from the tip of the device.Two (2) photographs of the 14f isleeve introducer sheath post procedure was provided and reviewed by a bsc quality technician.Both photographs showed the 14f isleeve introducer sheath with an expanded seam and tip split.Images of the torn section of the device tip were not provided for review.

• Brand Name: ISLEEVE 14F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22090216
• Report Number: 2124215-2025-32639
• Device Sequence Number: 7885059
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: (01)08714729950660(17)270203(10)35764522
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 08/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0035764522
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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
• Patient Sex: Unknown