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

Model Number 10445

Device Problem Material Integrity Problem (2978)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Vascular Dissection (3160)

Event Date 03/01/2024

Event Type  Injury  

Event Description

It was reported the tip split in an atypical manner and femoral artery dissection occurred.Procedure summary during a transcatheter aortic valve replacement (tavr) procedure, vascular access was obtained via a mildly tortuous, mildly calcified transfemoral approach.The mildly calcified native aortic annulus measured 21.3mm in diameter.A 14f sleeve introducer sheath was placed and non-boston scientific (bsc) guidewire was advanced into position.Balloon aortic valvuloplasty (bav) was performed with an 18mm non-bsc balloon catheter in accordance with the instructions for use (ifu).A size small accurate neo2 valve was prepared and loaded onto an accurate neo2 transfemoral (tf) delivery system (ds) in accordance with the ifu.The accurate neo2 tf ds was advanced and the accurate neo2 valve was released at the intended location.Following successful implantation of the accurate neo2 valve, the accurate neo2 tf ds was withdrawn.During removal of the 14f sleeve introducer sheath resistance was encountered as the tip of the 14f sleeve introducer sheath exited the patient.Echocardiogram identified a dissection in the right femoral artery.The 14f sleeve introducer sheath was examined and it was discovered the tip was split in an atypical manner.A closure device was placed and manual pressure was applied to the right leg until bleeding ceased.Patient status the patient fully recovered.

• 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: 18849516
• MDR Text Key: 337035502
• Report Number: 2124215-2024-12876
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/06/2024

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
• Device Operator: Health Professional
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0033055284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Female