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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
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.Femoral access was obtained via the mildly tortuous, non-calcified, right femoral artery with a diameter measuring 5.6mm.The 14f isleeve introducer sheath was placed in the femoral artery.The tavr procedure was successfully performed.During removal of the 14f isleeve introducer sheath from the patient it was discovered a fragment of the radiopaque tip had detached.The detached tip fragment was located under the skin near the femoral puncture site.The operators removed the detached tip fragment using surgical forceps.No patient complications were reported.
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.Femoral access was obtained via the mildly tortuous, non-calcified, right femoral artery with a diameter measuring 5.6mm.The 14f isleeve introducer sheath was placed in the femoral artery.The tavr procedure was successfully performed.During removal of the 14f isleeve introducer sheath from the patient it was discovered a fragment of the radiopaque tip had detached.The detached tip fragment was located under the skin near the femoral puncture site.The operators removed the detached tip fragment using surgical forceps.No patient complications were reported.It was further reported the 14f isleeve introducer sheath was used in conjunction with an acurate prime delivery system and safari2 guidewire.
Additional Manufacturer Narrative
This supplemental report is being submitted with an update to sections: b5 describe event or problem.H6 device codes.H6 evaluation method codes.H6 evaluation result codes.H6 evaluation conclusion codes.Device technical analysis: the 14f isleeve introducer sheath was returned and device analysis was performed by a bsc quality technician.The returned device consisted of a 14f isleeve introducer sheath with the dilator pushed completely through the sheath and protruded from the sheath tip.The device was visually and microscopically evaluated.The 14f isleeve introducer sheath was kinked in numerous locations.Two (2) of three (3) expansion seams were expanded with the tip split at one (1) seam.The expanded seams and tip of the 14f isleeve introducer sheath occurred along the seam line and is expected during use of the device; therefore, this is not considered device damage.A portion of the tip was detached and not returned for analysis.One (1) image of fluoroscopy was provided and reviewed by a bsc quality technician.The fluoroscopic image showed the distal end and tip of the 14f isleeve introducer sheath inside the patient with a solid piece of foreign material (fm) above the tip area, which was most likely the detached portion of the tip.One (1) photograph of the 14f isleeve introducer sheath post procedure was provided and reviewed by a bsc quality technician.The photograph showed the distal end and tip of the 14f isleeve introducer sheath with blood on the outside.There was one (1) expanded seam.The tip showed that it was split along the back and a port of the tip missing on the top portion.

• 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: 21985558
• Report Number: 2124215-2025-29308
• Device Sequence Number: 8312564
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: (01)08714729950660(17)260319(10)33657896
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 08/01/2025

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: 03/19/2026
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0033657896
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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