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

Model Number	10445
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a sheath liner tear occurred.During a transcatheter aortic valve replacement (tavr) procedure vascular access was obtained via a severely calcified, moderately tortuous, moderately stenotic transfemoral approach.An attempt was made to advance a 14f isleeve introducer sheath and difficulty was encountered due to the femoral calcifications and tortuosity.Upon removal, the 14f isleeve introducer sheath was observed to be compressed and near the tip of the device a tear through the sheath liner inconsistent with the expected seam expansion was identified.The femoral artery was dilated with an unknown 16f introducer sheath and a new 14f isleeve introducer sheath was used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
H6 device codes updated.H6 component codes updated.H6 evaluation method codes updated.H6 evaluation result codes updated.H6 evaluation conclusion codes updated.Media analysis: two (2) photographic images of the 14f isleeve introducer sheath were received and analyzed by a bsc quality technician.The photographs were reviewed and showed multiple kinks in the sheath and that the sheath was twisted.There was a seam at the distal end of the sheath that appeared to be expanded, not torn.The expanded seam of the 14 f isleeve introducer sheath occurred along the seam line and is expected use of the device, as the seams are designed to expand with use to allow passage of a delivery system or balloon aortic valvuloplasty (bav) catheter; therefore, is not considered damage to the device.Analysis of the photographic images confirmed there was damage to the 14f isleeve introducer sheath however, there was no sheath tear/break.
Event or Problem Description
It was reported a sheath liner tear occurred.Procedure summary: during a transcatheter aortic valve replacement (tavr) procedure vascular access was obtained via a severely calcified, moderately tortuous, moderately stenotic transfemoral approach.An attempt was made to advance a 14f isleeve introducer sheath and difficulty was encountered due to the femoral calcifications and tortuosity.Upon removal, the 14f isleeve introducer sheath was observed to be compressed and near the tip of the device a tear through the sheath liner inconsistent with the expected seam expansion was identified.The femoral artery was dilated with an unknown 16f introducer sheath and a new 14f isleeve introducer sheath was used to complete the procedure.Patient status: no patient complications were reported.

• 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: 21439430
• Report Number: 2124215-2025-08978
• Device Sequence Number: 4336970
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 03/03/2025

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 Expiration Date: 08/07/2026
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0034585653
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female