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

Model Number	10445
Medical Device Problem Codes	Defective Device (2588); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that difficult to advance occurred.A transcatheter aortic valve implant procedure was being performed utilizing a 14f isleeve introducer sheath for femoral access.While trying to advance the 14f isleeve introducer sheath, a lot of resistance was encountered at the iliac artery as there was a tight curve in the anatomy.The 14f isleeve introducer sheath was removed and it was found to be squished and not suitable for use.The 14f isleeve introducer sheath was discarded.The procedure was completed with a different 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20300402
• Report Number: 2124215-2024-59704
• Device Sequence Number: 8759088
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

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: 03/28/2026
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0033718495
• 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: 09/11/2024
• Initial Report FDA Received Date: 09/25/2024
• Date Device Manufactured: 03/28/2024
• 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 Age: 73 YR
• Patient Sex: Male