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	04/02/2025
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 mildly stenotic, mildly calcified, mildly tortuous femoral artery.A balloon aortic valvuloplasty (bav) balloon catheter, an unknown manufacturer's valve delivery system, and a post-dilatation bav balloon catheter were passed through the 14f isleeve introducer sheath.At the conclusion of the procedure during removal of the 14f isleeve introducer sheath, resistance was encountered.After removal from the patient it was observed the tip of the 14f isleeve introducer sheath was torn in an atypical manner with a partially detached flap.No patient complications were reported.
Additional Manufacturer Narrative
H3 device evaluated by mfr: the 14f isleeve introducer sheath was returned and device analysis was performed by a bsc quality technician.The returned device consisted of an 14f isleeve introducer sheath with the dilator completely through the sheath and protruding out of the tip of the 14f isleeve introducer sheath.Visual and microscopic examination of the 14f isleeve introducer sheath identified two (2) of the expansion seams were expanded and the device tip was split on both sides of one (1) seam and beginning to split at another seam.As the seams are designed to expand and the tip to split with use to allow passage ancillary devices, this is not considered damage to the device.In addition to the tip split, as the tip was split on both sides of one (1) seam a portion of the tip was torn creating a flap.The tip was also damaged in multiple locations.
Event or Problem Description
It was reported that tip tore in a manner with a partially detached flap.A 14f isleeve introducer sheath was used during a transcatheter aortic valve replacement (tavr) procedure.The 14f isleeve introducer sheath was placed in the mildly stenotic, mildly calcified, mildly tortuous femoral artery.A balloon aortic valvuloplasty (bav) balloon catheter, an unknown manufacturer's valve delivery system, and a post-dilatation bav balloon catheter were passed through the 14f isleeve introducer sheath.At the conclusion of the procedure during removal of the 14f isleeve introducer sheath, resistance was encountered.After removal from the patient it was observed the tip of the 14f isleeve introducer sheath was torn in a manner with a partially detached flap.No patient complications were reported.It was further reported the valve delivery system used was an accurate prime delivery system.Bav and post dilatation bav was performed with a 22mm tru dilatation balloon.

• 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: 21801139
• Report Number: 2124215-2025-21001
• Device Sequence Number: 8311359
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: (01)08714729950660(17)270113(10)35611522
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 07/02/2025

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: 0035611522
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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