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

Model Number 10445

Device Problems Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 07/05/2023

Event Type  malfunction  

Event Description

It was reported that difficulty to advance within the artery occurred.Procedure summary a 14f isleeve introducer sheath was selected for use in a transcatheter aortic valve replacement (tavr) procedure.The femoral vasculature contained moderate calcification and tortuosity.Vascular access was obtained via a right transfemoral approach.A 14f isleeve introducer sheath was prepared in accordance with the instructions for use (ifu).During introduction of the 14f isleeve introducer sheath into the right femoral artery, the physician encountered difficulty advancing the 14f isleeve introducer sheath within the artery.The 14f isleeve introducer sheath was removed from the patient.Once outside the patient, a kink was observed in the 14f isleeve introducer sheath, approximately 14cm from the hemostatic valve.The physician pre-dilated the right common femoral artery and right external iliac artery with 12f, 14f, and 16f dilators.A second 14f isleeve introducer sheath was prepared in accordance with the ifu.Prior to introduction of the second 14f isleeve introducer sheath into the patient, it was observed that a seam of the 14f isleeve had prematurely expanded.The 14f isleeve introducer sheath was exchanged.A third 14f isleeve introducer sheath was prepared in accordance with the ifu.Prior to introduction of the third 14f isleeve introducer sheath into the patient, a premature seam expansion was noted.The 14f isleeve introducer sheath was exchanged.A fourth 14f isleeve introducer sheath was prepared in accordance with the ifu and was successfully utilized to complete the tavr procedure.Patient status no patient complications were reported.

Manufacturer Narrative

Device analysis by manufacturer: the 14f isleeve introducer sheath was returned for device analysis with the dilator in the sheath.Visual and microscopic analysis of the dilator, tip, sheath, and hub/valve were completed, revealing the seams were expanded.Seam 1 was expanded from approximately 17.5 to 21.5cm.Seam 2 was expanded from approximately 16cm to 21cm.Seam 3 was expanded from approximately 18.5cm to 20.5cm.Additionally, kinks/buckling were observed at 18cm to 19cm proximal of the sheath tip.Additionally, three photos were provided to aid in the investigation and were reviewed by a bsc quality engineer.The photos depicted the kink in the 14f isleeve introducer sheath.Product analysis confirmed the reported event of sheath kink as the isleeve 14f sheath was kinked.Product analysis could not confirm the reported event of difficulty advancing as clinical circumstances could not be replicated; however, it is most likely that the kinks contributed to the difficulty to advance.Inspection of the device found the seams were expanded.The observed damage was attributed to procedural factors as the most likely cause of the damage is due to the forces that are put upon the sheath during insertion, advancing, and manipulation.

Event Description

It was reported that difficulty to advance within the artery occurred.Procedure summary: a 14f isleeve introducer sheath was selected for use in a transcatheter aortic valve replacement (tavr) procedure.The femoral vasculature contained moderate calcification and tortuosity.Vascular access was obtained via a right transfemoral approach.A 14f isleeve introducer sheath was prepared in accordance with the instructions for use (ifu).During introduction of the 14f isleeve introducer sheath into the right femoral artery, the physician encountered difficulty advancing the 14f isleeve introducer sheath within the artery.The 14f isleeve introducer sheath was removed from the patient.Once outside the patient, a kink was observed in the 14f isleeve introducer sheath, approximately 14cm from the hemostatic valve.The physician pre-dilated the right common femoral artery and right external iliac artery with 12f, 14f, and 16f dilators.A second 14f isleeve introducer sheath was prepared in accordance with the ifu.Prior to introduction of the second 14f isleeve introducer sheath into the patient, it was observed that a seam of the 14f isleeve had prematurely expanded.The 14f isleeve introducer sheath was exchanged.A third 14f isleeve introducer sheath was prepared in accordance with the ifu.Prior to introduction of the third 14f isleeve introducer sheath into the patient, a premature seam expansion was noted.The 14f isleeve introducer sheath was exchanged.A fourth 14f isleeve introducer sheath was prepared in accordance with the ifu and was successfully utilized to complete the tavr procedure.Patient status: no patient complications 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: 17294996
• MDR Text Key: 319378476
• Report Number: 2124215-2023-35746
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 09/25/2023

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
• Device Operator: Health Professional
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0031196257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 09/13/2023
• Supplement Dates FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Female