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

Model Number	10445
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a sheath liner tear occurred.A 14f isleeve introducer sheath was used during a transcatheter aortic valve replacement (tavr) procedure.Femoral access was obtained via the mildly calcified, mildly stenotic, moderately tortuous femoral artery.A safari2 guidewire, 20mm non-boston scientific (bsc) pre-dilatation balloon catheter, and 23-25mm acurate prime delivery system were passed through the 14f isleeve introducer sheath without issue.The tavr procedure was successfully completed.At the conclusion of the procedure difficulty was encountered removing the 14f isleeve introducer sheath.Upon removal a tear through the sheath liner at the distal end was observed.No patient complications were reported.
Event or Problem Description
It was reported that a sheath liner tear occurred.Procedure summary a 14f isleeve introducer sheath was used during a transcatheter aortic valve replacement (tavr) procedure.Femoral access was obtained via the mildly calcified, mildly stenotic, moderately tortuous femoral artery.A safari2 guidewire, 20mm non-boston scientific (bsc) pre-dilatation balloon catheter, and 23-25mm acurate prime delivery system were passed through the 14f isleeve introducer sheath without issue.The tavr procedure was successfully completed.At the conclusion of the procedure difficulty was encountered removing the 14f isleeve introducer sheath.Upon removal a tear through the sheath liner at the distal end was observed.Patient status 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 boston scientific quality technician.The returned device consisted of a 14f isleeve introducer sheath with the dilator pushed completely through the sheath and protruded from the sheath tip.The device was visually and microscopically evaluated.The 14f isleeve introducer sheath was kinked approximately 15.25cm and 20cm distal of the strain relief.Two (2) of the three (3) expansion seams were expanded with the tip split at one of the seams.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 of the 14f isleeve introducer sheath was split along both sides of an expansion seam causing a portion of the tip to protrude upward creating a flap.No sheath liner tear was present.

• 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: 21882158
• Report Number: 2124215-2025-23992
• Device Sequence Number: 8631504
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: (01)08714729950660(17)260520(10)34064918
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/03/2025

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: 05/20/2026
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0034064918
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• 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