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

Model Number	10445
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.The patient's anatomy contained a native aortic annulus measuring 27.5mm in diameter with moderate to severe calcification.The left coronary artery (lca) distance measured 8.9mm.The femoral arteries contained extreme tortuosity.At the beginning of the procedure, the patient had a blood pressure under 70mmhg and an ejection fraction <30%.The lca was protected.Vascular access was obtained via a transfemoral approach.A 14f isleeve introducer sheath was advanced.A safari2 guidewire was advanced and positioned in the left ventricle.Balloon aortic valvuloplasty (bav) was performed with one inflation of a 24mm non-boston scientific (bsc) balloon catheter.Commissural alignment was performed.A 29mm acurate prime valve was prepared and loaded onto an acurate prime delivery system (ds).The acurate prime ds was advanced into position.The 29mm acurate prime valve was deployed, moved up and was under expanded.A 26mm non-bsc valve was prepared and delivered through the 14f isleeve introducer sheath.Once at the level of the descending aorta, it was observed that part of the 14f isleeve introducer sheath tip chipped and was attached to the non-bsc valve delivery system.The non-bsc valve system was removed along with the 14f isleeve introducer sheath.A 22fr non-bsc introducer sheath was placed and a new non-bsc valve was implanted as a valve-in-valve.There was no lca blood flow obstruction.Once the 14f isleeve introducer sheath was removed from the patient, the chipped part attached to the non-bsc delivery system was confirmed to fit the hole in the 14f isleeve introducer sheath and there were no concerns of fragments left inside the patient.No patient complications were reported.
Additional Manufacturer Narrative
Photos of the 14f isleeve introducer sheath was provided to aid in the investigation and was reviewed by a bsc quality technician.The photos showed a portion of the 14f isleeve introducer sheath tip detached, confirming the reported allegations.
Event or Problem Description
It was reported that tip detachment occurred.The patient's anatomy contained a native aortic annulus measuring 27.5mm in diameter with moderate to severe calcification.The left coronary artery (lca) distance measured 8.9mm.The femoral arteries contained extreme tortuosity.At the beginning of the procedure, the patient had a blood pressure under 70mmhg and an ejection fraction <30%.The lca was protected.Vascular access was obtained via a transfemoral approach.A 14f isleeve introducer sheath was advanced.A safari2 guidewire was advanced and positioned in the left ventricle.Balloon aortic valvuloplasty (bav) was performed with one inflation of a 24mm non-boston scientific (bsc) balloon catheter.Commissural alignment was performed.A 29mm acurate prime valve was prepared and loaded onto an acurate prime delivery system (ds).The acurate prime ds was advanced into position.The 29mm acurate prime valve was deployed, moved up and was under expanded.A 26mm non-bsc valve was prepared and delivered through the 14f isleeve introducer sheath.Once at the level of the descending aorta, it was observed that part of the 14f isleeve introducer sheath tip chipped and was attached to the non-bsc valve delivery system.The non-bsc valve system was removed along with the 14f isleeve introducer sheath.A 22fr non-bsc introducer sheath was placed and a new non-bsc valve was implanted as a valve-in-valve.There was no lca blood flow obstruction.Once the 14f isleeve introducer sheath was removed from the patient, the chipped part attached to the non-bsc delivery system was confirmed to fit the hole in the 14f isleeve introducer sheath and there were no concerns of fragments left inside the patient.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: 21972103
• Report Number: 2124215-2025-28720
• Device Sequence Number: 15484559
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: (01)08714729950660(17)260919(10)34885721
• 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): 07/09/2025

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: 09/19/2026
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0034885721
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 07/09/2025
• Date Device Manufactured: 09/19/2024
• 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