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

Model Number	10445
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.Procedure summary.A 14f isleeve introducer sheath was used during a transcatheter aortic valve replacement (tavr) procedure.The 14f isleeve introducer sheath was placed and a 27mm non-boston scientific (bsc) tavr delivery system was advanced.After the non-bsc delivery system had passed through the 14f isleeve introducer sheath it was observed the tip of the isleeve had detached.The 27mm non-bsc delivery system was withdrawn.The detached 14f isleeve introducer sheath tip was snared and removed from the patient.The 27mm non-bsc delivery system was readvanced through the 14f isleeve introducer sheath.The 27mm non-bsc valve was successfully implanted and the procedure completed.Patient status no patient complications were reported.The patient has fully recovered.
Additional Manufacturer Narrative
This supplemental report is being submitted with updates to sections: d4 lot number.D4 expiration date.G1 mfr site facility name.G1 mfr site address 1.G1 mfr site city.G1 mfr site state.G1 mfr site country.
Event or Problem Description
It was reported that tip detachment occurred.A 14f isleeve introducer sheath was used during a transcatheter aortic valve replacement (tavr) procedure.The 14f isleeve introducer sheath was placed and a 27mm non-boston scientific (bsc) tavr delivery system was advanced.After the non-bsc delivery system had passed through the 14f isleeve introducer sheath it was observed the tip of the isleeve had detached.The 27mm non-bsc delivery system was withdrawn.The detached 14f isleeve introducer sheath tip was snared and removed from the patient.The 27mm non-bsc delivery system was readvanced through the 14f isleeve introducer sheath.The 27mm non-bsc valve was successfully implanted and the procedure completed.There were no patient complications were reported.The patient has fully recovered and was discharged per normal protocol.
Event or Problem Description
It was reported that tip detachment occurred.A 14f isleeve introducer sheath was used during a transcatheter aortic valve replacement (tavr) procedure.The 14f isleeve introducer sheath was placed and a 27mm non-boston scientific (bsc) tavr delivery system was advanced.After the non-bsc delivery system had passed through the 14f isleeve introducer sheath it was observed the tip of the isleeve had detached.The 27mm non-bsc delivery system was withdrawn.The detached 14f isleeve introducer sheath tip was snared and removed from the patient.The 27mm non-bsc delivery system was readvanced through the 14f isleeve introducer sheath.The 27mm non-bsc valve was successfully implanted and the procedure completed.There were no patient complications were reported.The patient has fully recovered and was discharged per normal protocol.
Additional Manufacturer Narrative
This supplemental report is being submitted with updates to sections: h6 component codes updated, h6 evaluation method codes updated, h6 evaluation result codes updated, h6 evaluation conclusion codes updated.Device analysis: the 14f isleeve introducer sheath was returned and device analysis was performed by a boston scientific quality technician.The 14f isleeve introducer sheath was received with the dilator outside of the sheath.The detached portion of the tip was also returned.Visual and microscopic analysis was performed.All three expansion seams were expanded with the tip split at one of the seams.The expanded seams and tip split occurred along the seam lines which is expected during use of the device.As the expansion seams and tip are designed to expand with use to allow passage of a delivery system during the procedure this seam expansion and tip split are not considered damage to the device.A portion of the 14f isleeve introducer sheath at the sheath to tip transition was torn and had detached from the device.

• 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: 21233646
• Report Number: 2124215-2025-02854
• Device Sequence Number: 15603993
• 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,Followup
• Report Date (Section B): 04/30/2025

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: 10/04/2026
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0034994399
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 02/04/2025; 04/18/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/13/2025; 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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 Sex: Unknown