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

Model Number	10445
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
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 tortuous femoral artery.A safari2 guidewire and unknown pre-dilatation balloon catheter were advanced through the 14f isleeve introducer sheath.Difficulty was encountered removing the balloon catheter through the tip of the 14f isleeve introducer sheath.The balloon catheter was inflated, deflated, and a second attempt at removal was unsuccessful.The 14f isleeve introducer sheath and balloon catheter were removed as a unit and a sheath liner tear and tip damage were noted.A new 14f isleeve introducer sheath was used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
This supplemental report is being submitted with an update to sections: h6 component codes.H6 evaluation method codes.H6 evaluation result codes.H6 evaluation conclusion codes.Media review: one (1) photograph was provided to assist in the investigation and was reviewed by a boston scientific quality technician.The photograph showed the distal end of the 14f isleeve introducer sheath with expanded seams, sheath buckling, and tip damage.A balloon catheter protruded from the tip of the 14f isleeve introducer sheath and a portion of the distal end of the balloon catheter appeared to be inflated or not rewrapped.Seam expansion is expected during use of the device; therefore, this is not considered device damage.Analysis of the device photograph could not confirm the reported sheath tear.
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 tortuous femoral artery.A safari2 guidewire and unknown pre-dilatation balloon catheter were advanced through the 14f isleeve introducer sheath.Difficulty was encountered removing the balloon catheter through the tip of the 14f isleeve introducer sheath.The balloon catheter was inflated, deflated, and a second attempt at removal was unsuccessful.The 14f isleeve introducer sheath and balloon catheter were removed as a unit and a sheath liner tear and tip damage were noted.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: 21881773
• Report Number: 2124215-2025-23998
• Device Sequence Number: 7865391
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: (01)08714729950660(17)260925(10)34924425
• 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): 05/22/2025

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: 09/25/2026
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0034924425
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/22/2025
• Date Device Manufactured: 09/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown