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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an atypical tip split occurred.A 14f isleeve introducer sheath was used during a transcatheter aortic valve replacement (tavr) procedure.An acurate neo2 ds was advanced through the 14f isleeve introducer sheath.An acurate neo2 valve was successfully implanted.At the conclusion of the procedure, the 14f isleeve introducer sheath was removed and it was identified that the tip of the 14f isleeve introducer sheath had split in an atypical manner with a partially detached flap visible.No patient complications were reported.
Additional Manufacturer Narrative
Two (2) photographs of the 14f isleeve introducer sheath were received and analyzed by a boston scientific laboratory technician.The photographs showed the 14f isleeve introducer sheath with an expanded seam, tip split, and atypical tip damage.The expanded seam and tip split at the seam line are not considered damage as the seams and tip are designed to expand with use to allow passage of a delivery system and balloon aortic valvuloplasty (bav) balloon catheter during the procedure.In addition to the expected seam expansion and tip split, the tip was damaged in an atypical manner.Analysis of the photographic images confirmed the reported atypical device tip damage.
Event or Problem Description
It was reported that device tip damage 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 a tear at the tip of the device was identified with a partially detached flap.Patient status 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20292857
• Report Number: 2124215-2024-58672
• Device Sequence Number: 7284243
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/15/2024

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: 06/17/2026
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0034251455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/15/2024
• Date Device Manufactured: 06/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown