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 23.1mm 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 twice with a 22mm non-bsc balloon catheter in accordance with the instructions for use (ifu).A medium 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.

Manufacturer Narrative

H3 device evaluated by mfr: the returned device consisted of a 14f isleeve introducer sheath with the dilator.The dilator was not received inside the 14f isleeve introducer sheath.Blood was present on the outside of the 14f isleeve introducer sheath.Two (2) of the three (3) seams were expanded with the tip split at one of the seams.The expanded seams and tip of the 14f isleeve introducer sheath occurred along the seam line and is expected with use of the 14f isleeve introducer sheath.The seams and tip of the 14f isleeve introducer sheath are designed to expand with use to allow passage of a delivery system and balloon aortic valvuloplasty during the procedure.Therefore, this is not considered damage to the 14f isleeve introducer sheath.The tip of the 14f isleeve introducer sheath was also damaged on both sides, as material was lifted/pulled up in a few locations.Product analysis confirmed the that the tip of the 14f isleeve introducer sheath was damaged but it was not split in atypical manner.A photographic image was provided to aid in the investigation and was reviewed by a bsc quality technician.The photograph showed the tip of the 14f isleeve introducer sheath was split; however, no other damage was identified in photograph.

Event Description

It was reported that sheath tip damage occurred.Procedure summary: the native aortic annulus was 23.1mm 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 twice with a 22mm non-bsc balloon catheter in accordance with the instructions for use (ifu).A medium 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: 19175414
• MDR Text Key: 341037725
• Report Number: 2124215-2024-24552
• 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: 04/24/2024

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: 0032875356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female