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

Model Number 10445

Device Problems Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2024

Event Type  malfunction  

Event Description

It was reported that sheath tip damage occurred.Procedure summary.The native aortic annulus was 26.6mm in diameter with mild tortuosity and moderate calcification.Vascular access was obtained via a transfemoral approach.A 14f isleeve introducer sheath was inserted.A safari2 guidewire was advanced into position.Balloon aortic valvuloplasty (bav) was performed with a 24mm non-bsc balloon catheter in accordance with the instructions for use (ifu).A large size acurate neo2 valve was loaded onto an acurate neo2 transfemoral delivery system (tf ds) in accordance with the ifu.The acurate neo2 tf ds was advanced into position and the acurate neo2 valve was successfully implanted to treat the native aortic annulus.The acurate neo2 tf ds was removed from the patient with no issues noted.While the physician was removing the 14f isleeve introducer sheath it was noted that there was some resistance felt when pulling back from the vessel and that the tip of the sheath had split in an atypical manner.Patient status: no patient consequences were reported.

• Brand Name: ISLEEVE 14F
• Type of Device: 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: 19167918
• MDR Text Key: 340959970
• Report Number: 2124215-2024-24548
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0032889209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1