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

Model Number 10445

Device Problem Material Integrity Problem (2978)

Patient Problem Vascular Dissection (3160)

Event Date 02/20/2024

Event Type  malfunction  

Event Description

It was reported the tip split in an atypical manner and vessel dissection occurred.During an accurate neo2 transcatheter aortic valve replacement (tavr) procedure, vascular access was obtained via a transfemoral approach.The femoral artery was mildly tortuous.A14f isleeve introducer sheath was placed.A size small acurate neo2 valve was prepared and loaded onto an acurate neo2 transfemoral delivery system (tf ds).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.The dilator of the 14f isleeve introducer sheath was advanced into the 14f isleeve for removal.Upon removal from the patient, the tip of the 14f isleeve introducer sheath was observed to have split in an atypical manner with a portion of the tip sticking out.Angiography revealed a dissection at the femoral artery.Digital pressure was applied.The procedure was concluded.In the physician's opinion, the vessel dissection was attributed to the atypical splitting of the 14f isleeve introducer sheath distal tip.Patient was discharged in stable condition.The patient has fully recovered.

Manufacturer Narrative

Media was received and reviewed by a bsc quality engineer.Five (5) photographic images were made available to aid in the investigation analysis and were reviewed by a bsc quality technician.The photos showed multiple views of the 14f isleeve introducer sheath and tip.It appeared that the 14f isleeve introducer sheath was expanded, and the 14f isleeve introducer tip had been torn at the seam with some of the tip pulled/torn away from the 14f isleeve introducer sheath like a flap.The expanded seams of the 14f isleeve introducer and the split tip occurred along the seam line, and are expected use of the 14f isleeve introducer, as the seams and tip are designed to expand with use to allow passage of acurate neo2 transfemoral delivery system (tf ds) and balloon aortic valvuloplasty (bav) during the procedure; therefore, are not considered damage to the device.Review of the attached photos confirmed that the 14f isleeve introducer sheath tip was partially torn/detached in an atypical manner.

Event Description

It was reported the tip split in an atypical manner and vessel dissection occurred.During an acurate neo2 transcatheter aortic valve replacement (tavr) procedure, vascular access was obtained via a transfemoral approach.The femoral artery was mildly tortuous.A14f isleeve introducer sheath was placed.A size small acurate neo2 valve was prepared and loaded onto an acurate neo2 transfemoral delivery system (tf ds).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.The dilator of the 14f isleeve introducer sheath was advanced into the 14f isleeve for removal.Upon removal from the patient, the tip of the 14f isleeve introducer sheath was observed to have split in an atypical manner with a portion of the tip sticking out.Angiography revealed a dissection at the femoral artery.Digital pressure was applied.The procedure was concluded.In the physician's opinion, the vessel dissection was attributed to the atypical splitting of the 14f isleeve introducer sheath distal tip.Patient was discharged in stable condition.The patient has 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: 18845845
• MDR Text Key: 336992601
• Report Number: 2124215-2024-13437
• 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,Followup
• Report Date: 05/23/2024

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: 0032642514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention