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

Model Number	10445
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Vascular Dissection (3160)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an atypical tip tear occurred.Procedure summary: a 14f isleeve introducer sheath was used during a transcatheter aortic valve replacement (tavr) procedure.At the conclusion of the procedure when the 14f isleeve introducer sheath was removed bleeding at the femoral access site occurred.A small femoral artery dissection was suspected.A new dilator and closure device were placed, pressure was applied, and fluoroscopy showed the bleeding resolved.When the 14f isleeve introducer sheath was removed from the patient an atypical tear at the tip of the device was identified with a partially detached flap.Patient status: the patient fully recovered and was discharged.
Additional Manufacturer Narrative
H6 component codes updated.H6 evaluation method codes updated.H6 evaluation result codes updated.H6 evaluation conclusion codes updated.Returned device 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.Two (2) of the three (3) expansion seams were expanded with the tip split at two of these seams.The expanded seams of the 14f isleeve introducer sheath and one of the two tip splits occurred along the seam line and 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 balloon aortic valvuloplasty (bav) catheter; therefore, this is not considered device damage.The second tip split occurred at a different expansion seam and a portion of the sheath tip was torn/split at the transition which created a flap.Additional device tip damage was noted.The 14f isleeve introducer sheath tip was confirmed to be damaged in an atypical manner.A single device photograph was received and reviewed by a bsc quality engineer.The photograph showed the 14f isleeve introducer sheath tip which was torn in an atypical manner.The photograph matched the damage of the returned device.
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.At the conclusion of the procedure when the 14f isleeve introducer sheath was removed bleeding at the femoral access site occurred.A small femoral artery dissection was suspected.A new dilator and closure device were placed, pressure was applied, and fluoroscopy showed the bleeding resolved.When the 14f isleeve introducer sheath was removed from the patient an atypical tear at the tip of the device was identified with a partially detached flap.The patient fully recovered and 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: 21277610
• Report Number: 2124215-2025-01734
• Device Sequence Number: 9320553
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/26/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2026
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0033908919
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female