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	04/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that atypical tip split occurred.A transcatheter aortic valve implant (tavi) procedure was performed with use of an 14f isleeve introducer sheath for femoral access.During the tavi an acurate prime valve and delivery system were advanced through the 14f isleeve introducer sheath.At the conclusion of the tavi, after 14f isleeve introducer sheath withdrawal, the physician observed the tip of the 14f isleeve introducer sheath was split uncommonly.The tip was split only at one point, creating an anchor shape which the physician felt could be dangerous.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the 14f isleeve introducer sheath was returned and device analysis was performed by a bsc quality technician.The returned device consisted of an 14f isleeve introducer sheath with the dilator completely inside the sheath up to the hub with the tip protruding out of the tip.Visual and microscopic examination identified the 14f isleeve introducer sheath to be kinked in three (3) locations at approximately 18cm, 19cm, and 21.5cm distal of the strain relief.All three (3) seams were expanded, and the tip was split at the seam.As the seams are designed to expand and the tip to split with use to allow passage ancillary devices, this is not considered damage to the device.The tip was split on both sides of the seam so that a portion of the tip started to tear upwards creating a tab/flap, almost detached with only a small portion keeping the tab/flap attached to the remainder of the tip.Product analysis confirmed the tip was damaged.
Event or Problem Description
It was reported that the tip split in a manner creating an anchor shape occurred.A transcatheter aortic valve implant (tavi) procedure was performed with use of an 14f isleeve introducer sheath for femoral access.During the tavi an accurate prime valve and delivery system were advanced through the 14f isleeve introducer sheath.At the conclusion of the tavi, after 14f isleeve introducer sheath withdrawal, the physician observed the tip of the 14f isleeve introducer sheath was split uncommonly.The tip was split only at one point, creating an anchor shape which the physician felt could be dangerous.

• 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: 21980224
• Report Number: 2124215-2025-29094
• Device Sequence Number: 9017568
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: (01)08714729950660(17)260520(10)34064918
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 07/08/2025

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: 04/30/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 07/08/2025
• 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