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

Model Number	10445
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an atypical tip tear 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 moderately tortuous right femoral artery which had a diameter of 7mm.A 20mm non-boston scientific balloon aortic valvuloplasty balloon catheter and acurate neo2 transfemoral delivery system with acurate neo2 valve were advanced through the 14f isleeve introducer sheath.At the conclusion of the procedure resistance was encountered removing the 14f isleeve introducer sheath.After removal it was observed the tip of the 14f isleeve introducer sheath was had torn in an atypical manner with a partially detached flap.No patient complications were reported.
Additional Manufacturer Narrative
This final 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 analysis: two (2) photographs were provided to assist in the investigation and were reviewed by a bsc quality technician.The photographs showed the 14f isleeve introducer sheath the distal end and tip of the 14f isleeve introducer sheath with blood on the outside.There was an expanded seam (which is intended with the use of the device; therefore, is not considered device damage.) the tip was shown with multiple portions torn with a tab/flap appearance.
Event or Problem Description
It was reported that an atypical tip tear 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 moderately tortuous right femoral artery which had a diameter of 7mm.A 20mm non-boston scientific balloon aortic valvuloplasty balloon catheter and acurate neo2 transfemoral delivery system with acurate neo2 valve were advanced through the 14f isleeve introducer sheath.At the conclusion of the procedure resistance was encountered removing the 14f isleeve introducer sheath.After removal it was observed the tip of the 14f isleeve introducer sheath was had torn in an atypical manner with a partially detached flap.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: 21836607
• Report Number: 2124215-2025-22521
• Device Sequence Number: 8102036
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: (01)08714729950660(17)261015(10)35066064
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 05/19/2025

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 Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0035066064
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 05/19/2025
• Date Device Manufactured: 10/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown