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

Model Number	10445
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that atypical tip damage occurred.The patient's iliofemoral anatomy contained moderate tortuosity and severe calcification.Vascular access was obtained via a right-sided transfemoral approach.A 14f isleeve introducer sheath was advanced.An acurate neo2 valve system was advanced through the 14f isleeve introducer sheath and successfully implanted in the intended location.When closing femoral access and retrieving the 14f isleeve introducer sheath the physician noted that the tip of the 14f isleeve introducer sheath was ripped and significantly more flared than expected.The 14f isleeve introducer sheath was successfully removed using the dilator.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the 14f isleeve introducer sheath was returned for device analysis.The returned device consisted of the 14f isleeve introducer sheath and the dilator.The dilator was not inside the sheath.Visual inspection identified blood present inside the sheath, hub, and flush line.The sheath was kinked at 15cm distal of the strain relief of the hub.Two of the three seams were expanded with the tip split.Microscopic inspection identified the tip to be torn/split at a second seam with damage to the tip in this area.The expanded seams of the 14f isleeve introducer sheath and split tip occurred along the seam lines and is expected with use, as the seams and tip are designed to expand with use to allow passage of delivery system and balloon aortic valvuloplasty devices during the procedure.Therefore, these are not considered damage to the device.However, in addition to the split tip, damage to tip was also observed which is consistent with the reported event.Three photos of the 14f isleeve introducer sheath tip were provided to aid in the investigation and was reviewed by a bsc quality technician.The photos showed that there were a couple expanded seams, and the tip was split at the seam.The tip was also torn/split at a second seam with damage to the tip at this area.The photos are consistent with the damage observed on the returned 14f isleeve introducer sheath.
Event or Problem Description
It was reported that atypical tip damage occurred.The patient's iliofemoral anatomy contained moderate tortuosity and severe calcification.Vascular access was obtained via a right-sided transfemoral approach.A 14f isleeve introducer sheath was advanced.An acurate neo2 valve system was advanced through the 14f isleeve introducer sheath and successfully implanted in the intended location.When closing femoral access and retrieving the 14f isleeve introducer sheath the physician noted that the tip of the 14f isleeve introducer sheath was ripped and significantly more flared than expected.The 14f isleeve introducer sheath was successfully removed using the dilator.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: 20683904
• Report Number: 2124215-2024-71445
• Device Sequence Number: 8556962
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 12/30/2024

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: 08/17/2026
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0034657276
• 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: 11/12/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2024
• 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