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

Model Number	10445
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an atypical tip tear and a liner tear occurred.A 14f isleeve introducer sheath was used during a transcatheter aortic valve replacement (tavr) procedure.An unknown guidewire, unknown pigtail catheter, and acurate neo2 transfemoral (tf) delivery system (ds) were advanced and removed through the 14f isleeve introducer sheath with no resistance noted.At the conclusion of the procedure, after removal from the patient, it was observed the liner of the 14f isleeve introducer sheath was torn and 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
This supplemental report is being submitted with an update to sections: d4 lot number d4 expiration date h6 component 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 through the 14f isleeve introducer sheath and out the sheath tip.The 14f isleeve introducer sheath was visually and microscopically inspected.All three (3) expansion seams were expanded and the device tip was split along one (1) seam line.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.The tip of the 14f isleeve introducer sheath was partially torn along the sheath to tip transition causing a portion of the tip to protrude upward.There was also damage to the tip.No damage was identified on the sheath and no sheath tear was present.
Event or Problem Description
It was reported that a tip tear resulting in a partially detached flap and a liner tear occurred.A 14f isleeve introducer sheath was used during a transcatheter aortic valve replacement (tavr) procedure.An unknown guidewire, unknown pigtail catheter, and acurate neo2 transfemoral (tf) delivery system (ds) were advanced and removed through the 14f isleeve introducer sheath with no resistance noted.At the conclusion of the procedure, after removal from the patient, it was observed the liner of the 14f isleeve introducer sheath was torn and the tip of the 14f isleeve introducer sheath was 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: 21836637
• Report Number: 2124215-2025-22463
• Device Sequence Number: 15442398
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: (01)08714729950660(17)261015(10)35066064
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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): 06/30/2025

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: 0035185285
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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