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

Model Number	10445
Medical Device Problem Codes	Difficult to Remove (1528); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that vessel laceration occurred.During a transcatheter aortic valve replacement (tavr) procedure vascular access was obtained via a mildly calcified, mildly tortuous, severely stenotic transfemoral approach.The native aortic annulus measured 22.5mm in diameter.A 14f isleeve introducer sheath was placed and safari2 guidewire was advanced into position.Balloon aortic valvuloplasty (bav) was performed with one (1) inflation of a 20mm non-boston scientific (bsc) balloon catheter.An acurate neo2 valve size medium was prepared and loaded onto an acurate neo2 transfemoral (tf) delivery system (ds).The acurate neo2 tf ds was advanced into position, commissural alignment was achieved, and the acurate neo2 valve was successfully implanted at the intended location.During removal of the acurate neo2 tf ds tension was noted and angiography revealed the acurate neo2 tf ds was stuck at the tip of the 14f isleeve introducer sheath causing the introducer sheath to be deformed.The 14f isleeve introducer and acurate neo2 tf ds were removed together as a unit and a non-bsc dry seal sheath was placed.After removal of the 14f isleeve introducer sheath and acurate neo2 tf ds a vessel laceration was observed and femoral access was surgically closed.The patient fully recovered.
Additional Manufacturer Narrative
Device 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 without the dilator.The 14f isleeve introducer sheath was visually and microscopically inspected.The 14f isleeve introducer sheath was buckled approximately 18.5cm distal of the strain relief to the end of the introducer sheath.The sheath was pulled back and damaged at the sheath to tip transition for approximately 1cm.All three (3) expansion seams were expanded and the device tip was split along the seam lines.As the seams are designed to expand and the tip to split with use to allow passage of ancillary devices, this is not considered damage to the device.Microscopic analysis identified the tip of the device was damaged.
Event or Problem Description
It was reported that a difficulty removing the delivery system and vessel laceration occurred.During a transcatheter aortic valve replacement (tavr) procedure vascular access was obtained via a mildly calcified, mildly tortuous, severely stenotic transfemoral approach.The native aortic annulus measured 22.5mm in diameter.A 14f isleeve introducer sheath was placed and safari2 guidewire was advanced into position.Balloon aortic valvuloplasty (bav) was performed with one (1) inflation of a 20mm non-boston scientific (bsc) balloon catheter.An acurate neo2 valve size medium was prepared and loaded onto an acurate neo2 transfemoral (tf) delivery system (ds).The acurate neo2 tf ds was advanced into position, commissural alignment was achieved, and the acurate neo2 valve was successfully implanted at the intended location.During removal of the acurate neo2 tf ds tension was noted and angiography revealed the acurate neo2 tf ds was stuck at the tip of the 14f isleeve introducer sheath causing the introducer sheath to be deformed.The 14f isleeve introducer and acurate neo2 tf ds were removed together as a unit and a non-bsc dry seal sheath was placed.After removal of the 14f isleeve introducer sheath and acurate neo2 tf ds a vessel laceration was observed and femoral access was surgically closed.The patient fully recovered.It was further reported the patient was discharged.

• 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: 21763558
• Report Number: 2124215-2025-20599
• Device Sequence Number: 20948219
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: (01)08714729950660(17)260920(10)0034891706
• 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): 07/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2026
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0034891706
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown