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

Model Number	10445
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tip detachment occurred.A 14f isleeve introducer sheath was used during a transcatheter aortic valve replacement (tavr) procedure.The 14f isleeve introducer sheath was placed in the mildly calcified, mildly stenotic, and mildly tortuous femoral artery.An acurate prime delivery system with a loaded 23mm acurate prime valve was advanced.The 23mm acurate prime valve was successfully implanted.The operator reintroduced the 14 isleeve introducer sheath dilator, the non-boston scientific (bsc) suture-mediated closure device was closed, and the 14f isleeve introducer sheath was removed.Upon removal from the patient it was discovered a tip fragment of the 14f isleeve introducer sheath had detached and remained in the patient anatomy.Contrast assessment confirmed the tip fragment was in the patient's leg near the femoral puncture site.The decision was made to leave the tip fragment in place.Additional doppler imaging performed one (1) day post index procedure confirmed the tip fragment was extra-vascular.The physician suspected the 14f isleeve introducer sheath tip detachment was caused by the non-bsc closure device.The patient recovered and was discharged one (1) day post index procedure.
Event or Problem Description
It was reported that a tip detachment occurred.A 14f isleeve introducer sheath was used during a transcatheter aortic valve replacement (tavr) procedure.The 14f isleeve introducer sheath was placed in the mildly calcified, mildly stenotic, and mildly tortuous femoral artery.An acurate prime delivery system with a loaded 23mm acurate prime valve was advanced.The 23mm acurate prime valve was successfully implanted.The operator reintroduced the 14 isleeve introducer sheath dilator, the non-boston scientific (bsc) suture-mediated closure device was closed, and the 14f isleeve introducer sheath was removed.Upon removal from the patient it was discovered a tip fragment of the 14f isleeve introducer sheath had detached and remained in the patient anatomy.Contrast assessment confirmed the tip fragment was in the patient's leg near the femoral puncture site.The decision was made to leave the tip fragment in place.Additional doppler imaging performed one (1) day post index procedure confirmed the tip fragment was extra-vascular.The physician suspected the 14f isleeve introducer sheath tip detachment was caused by the non-bsc closure device.The patient recovered and was discharged one (1) day post index procedure.
Additional Manufacturer Narrative
H6 component codes updated.H6 evaluation method codes updated.H6 evaluation result codes updated.H6 evaluation conclusion codes updated.Device analysis: the 14f isleeve introducer sheath was returned and analyzed by a bsc quality technician.The 14f isleeve introducer sheath was returned with the dilator completely inside the sheath up to the hub with the tip of the dilator protruding out of the tip of the 14f isleeve introducer sheath.The 14f isleeve introducer sheath was visually and microscopically analyzed.Visual analysis identified numerous kinks on the sheath.Two (2) of the three (3) expansion seams were expanded with the tip split at one of the seams.The expanded seams and tip split occurred along the seam lines, which is expected during use of the device as the seams and tip are designed to expand with use to allow passage of a delivery system and/or balloon catheter.This anticipated seam expansion and tip split are not considered damage to the device.The 14f isleeve introducer sheath tip was torn at the transition of sheath to tip and a portion of the tip was detached.The detached portion was not returned with the device.One photograph was provided to assist in the investigation and was reviewed by a bsc quality technician.The photograph showed a portion of the distal end of the 14f isleeve introducer sheath with one of the seams expanded and the tip split and expanded.Based on the provided photograph, it was not able to be determined if a portion of the tip was detached as the tip was already split and expanded.

• 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: 21510384
• Report Number: 2124215-2025-12114
• Device Sequence Number: 18147925
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/09/2025

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: 06/14/2026
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0034241911
• 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: 02/25/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown