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

Model Number 10445

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/11/2023

Event Type  Injury  

Event Description

It was reported that a device tip detachment and unretrieved device fragments occurred.Procedure summary: vascular access was obtained via a transfemoral approach with a non-boston scientific (bsc) vascular closure device placed.The moderately calcified native aortic annulus was 23.8mm in diameter.A 14f isleeve introducer sheath was placed and a safari2 guidewire was advanced into position.A size medium accurate neo2 valve was prepared and loaded onto an acurate neo2 transfemoral (tf) delivery system (ds) in accordance with the instructions for use (ifu).The acurate neo2 tf ds was advanced and the acurate neo2 valve was released at the intended location.Balloon aortic valvuloplasty (bav) post-dilatation was performed with an unknown balloon catheter in accordance with the ifu.The safari2 guidewire and acurate neo2 tf ds were removed from the patient.During removal of the 14f isleeve introducer sheath, resistance was experienced at the femoral artery puncture site.The tip of the 14f isleeve detached from the device and a section measuring 3x5mm imbedded in tissue anterior to the right femoral artery puncture site.The detached section of the 14f isleeve remains imbedded in the patient tissue with no future interventions or retrievals planned.Patient status: no patient complications were reported.

• Brand Name: ISLEEVE 14F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16252197
• MDR Text Key: 308229781
• Report Number: 2124215-2023-02228
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (y/n): N
• Reporter Country Code: TC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2023

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: 0030272291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male