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

Model Number 10445

Device Problems Difficult to Advance (2920); Material Integrity Problem (2978)

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

Event Date 08/30/2022

Event Type  malfunction  

Event Description

It was reported that there was difficulty advancing the isleeve introducer sheath within the artery.Vascular access was obtained via a right transfemoral artery approach.The vasculature was tortuous with narrow and calcified access of the iliac arteries.Two unknown manufacturer's stents were located in the common iliac arteries prior to the index procedure, with one stent in each iliac artery.Intravascular lithotripsy was performed on the iliac arteries with a non-bsc device.A 14f isleeve introducer sheath was inserted; however, the 14f isleeve introducer sheath was unable to be advanced within the artery past the location of the previously implanted stent in the iliac artery.The 14f isleeve introducer sheath was removed from the patient.Dilatation of the previously implanted stent was performed.The physician readvanced the same 14f isleeve introducer sheath; however the same issue occurred.The 14f isleeve introducer sheath was removed from the patient, and tip damage was noted.A new 14f isleeve introducer sheath was prepared and advanced into the patient and was unable to be advanced within the artery past the location of the previously implanted stent.The 14f isleeve introducer sheath was removed from the patient.The procedure was successfully completed with a non-bsc introducer sheath.No patient complications were reported.

Event Description

It was reported that there was difficulty advancing the isleeve introducer sheath within the artery.Vascular access was obtained via a right transfemoral artery approach.The vasculature was tortuous with narrow and calcified access of the iliac arteries.Two unknown manufacturer's stents were located in the common iliac arteries prior to the index procedure, with one stent in each iliac artery.Intravascular lithotripsy was performed on the iliac arteries with a non-bsc device.A 14f isleeve introducer sheath was inserted; however, the 14f isleeve introducer sheath was unable to be advanced within the artery past the location of the previously implanted stent in the iliac artery.The 14f isleeve introducer sheath was removed from the patient.Dilatation of the previously implanted stent was performed.The physician readvanced the same 14f isleeve introducer sheath; however the same issue occurred.The 14f isleeve introducer sheath was removed from the patient, and tip damage was noted.A new 14f isleeve introducer sheath was prepared and advanced into the patient and was unable to be advanced within the artery past the location of the previously implanted stent.The 14f isleeve introducer sheath was removed from the patient.The procedure was successfully completed with a non-bsc introducer sheath.No patient complications were reported.

Manufacturer Narrative

Media was provided to aid in the investigation and was reviewed by a bsc medical director.The media was comprised of a 3-mensio report of the pre-planning computed tomography (ct) and pre-planning ct images.The pdf report of the planning ct showed a three-leaflet calcified aortic valve with 23.4mm of perimeter derived diameter.Evaluation of the peripheral arteries for femoral access revealed that there was a stent present in the aorta and in the proximal portion of both iliac arteries.The measurement of the iliac diameter showed diameters as low as 3.5x3.7mm (3.6mm average) in the left side and 3.8x6.2mm (average of 5.0mm) in the right side.Both the arteries are below the ifu recommended lowest limit of 5.5mm of diameter to use the 14f isleeve introducer sheath.Planning ct images were also measured and the diameters match the ones from the 3-mensio report.Upon review of the images, it can be concluded that the diameters of the iliac arteries were below the recommended limit to use the 14f isleeve introducer sheath.This might have played a role in the difficulty to advance the device.

Event Description

It was reported that there was difficulty advancing the isleeve introducer sheath within the artery.Procedure summary: vascular access was obtained via a right transfemoral artery approach.The vasculature was tortuous with narrow and calcified access of the iliac arteries.Two unknown manufacturer's stents were located in the common iliac arteries prior to the index procedure, with one stent in each iliac artery.Intravascular lithotripsy was performed on the iliac arteries with a non-bsc device.A 14f isleeve introducer sheath was inserted; however, the 14f isleeve introducer sheath was unable to be advanced within the artery past the location of the previously implanted stent in the iliac artery.The 14f isleeve introducer sheath was removed from the patient.Dilatation of the previously implanted stent was performed.The physician readvanced the same 14f isleeve introducer sheath; however the same issue occurred.The 14f isleeve introducer sheath was removed from the patient, and tip damage was noted.A new 14f isleeve introducer sheath was prepared and advanced into the patient and was unable to be advanced within the artery past the location of the previously implanted stent.The 14f isleeve introducer sheath was removed from the patient.The procedure was successfully completed with a non-bsc introducer sheath.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: 15440668
• MDR Text Key: 305344434
• Report Number: 2124215-2022-36405
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 10/31/2022

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 Expiration Date: 03/13/2024
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0029040440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 09/26/2022; 10/24/2022
• Supplement Dates FDA Received: 09/28/2022; 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male