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

Model Number	10445
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device detachment occurred.Procedure summary: the patient's native aortic annulus measured 22.7mm in diameter with moderate calcification.The patient's anatomy contained a horizontal aorta.Vascular access was obtained via a transfemoral approach.A 14f isleeve introducer sheath was advanced.A size small safari2 guidewire was advanced and positioned.Balloon aortic valvuloplasty (bav) was performed effectively with a 22mm non-boston scientific (bsc) balloon catheter.A three-cusp view was obtained.A size medium acurate neo2 valve was prepared and loaded onto an acurate neo2 transfemoral (tf) delivery system (ds).The acurate neo2 tf ds was advanced into position.Commissural alignment was successfully performed.The positioning was checked with contrast.Slow opening of knob one for initial release was performed.After initial release step one, contrast was injected and the size medium acurate neo2 valve was positioned too high.The physician repositioned to the correct height.Initial release step two was performed, contrast was injected, and the position of the size medium acurate neo2 valve was assessed to be good.Shortly before final release, it was observed that the acurate neo2 tf ds moved from the outer curve to the middle.After final release, the size medium acurate neo2 valve moved aortically and a severe pvl was observed.Contrast injection of the aortic root was performed.The size medium acurate neo2 valve was in contact with the native aortic annulus, positioned 1 mm too high and not obstructing the coronary arteries.A 26mm non-bsc valve was implanted as a valve-in-valve with good result.After the valve-in-valve implant, in reviewing the x-ray images, a piece of the 14f isleeve introducer sheath was identified on the 26mm non-bsc valve.The piece of 14f isleeve introducer sheath dislodged when the non-bsc valve was pushed forward and the 14f isleeve introducer sheath piece became lodged in the outer carotid artery.A neuro radiologist was consulted and was able to successfully retrieve the 14f isleeve introducer sheath piece percutaneously.Patient status: the patient remained stable throughout the procedure and no patient complications were reported.The patient has been discharged.It was further reported that no difficulties were encountered in advancing the 14f isleeve introducer sheath through the anatomy, nor were there any abnormal femoral anatomy characteristics.The piece of the 14f isleeve introducer sheath that detached was a part of the tip.The detached tip piece was retrieved with a non-bsc grasping device.
Additional Manufacturer Narrative
B5 - additional information added.H6 - evaluation method codes updated.
Event or Problem Description
It was reported that device detachment occurred.The patient's native aortic annulus measured 22.7mm in diameter with moderate calcification.The patient's anatomy contained a horizontal aorta.Vascular access was obtained via a transfemoral approach.A 14f isleeve introducer sheath was advanced.A size small safari2 guidewire was advanced and positioned.Balloon aortic valvuloplasty (bav) was performed effectively with a 22mm non-boston scientific (bsc) balloon catheter.A three-cusp view was obtained.A size medium acurate neo2 valve was prepared and loaded onto an acurate neo2 transfemoral (tf) delivery system (ds).The acurate neo2 tf ds was advanced into position.Commissural alignment was successfully performed.The positioning was checked with contrast.Slow opening of knob one for initial release was performed.After initial release step one, contrast was injected and the size medium acurate neo2 valve was positioned too high.The physician repositioned to the correct height.Initial release step two was performed, contrast was injected, and the position of the size medium acurate neo2 valve was assessed to be good.Shortly before final release, it was observed that the acurate neo2 tf ds moved from the outer curve to the middle.After final release, the size medium acurate neo2 valve moved aortically and a severe pvl was observed.Contrast injection of the aortic root was performed.The size medium acurate neo2 valve was in contact with the native aortic annulus, positioned 1 mm too high and not obstructing the coronary arteries.A 26mm non-bsc valve was implanted as a valve-in-valve with good result.After the valve-in-valve implant, in reviewing the x-ray images, a piece of the 14f isleeve introducer sheath was identified on the 26mm non-bsc valve.The piece of 14f isleeve introducer sheath dislodged when the non-bsc valve was pushed forward and the 14f isleeve introducer sheath piece became lodged in the outer carotid artery.A neuro radiologist was consulted and was able to successfully retrieve the 14f isleeve introducer sheath piece percutaneously.The patient remained stable throughout the procedure and no patient complications were reported.The patient has been discharged.

• Brand Name: ISLEEVE 14F
• Common Device Name: 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: 20677807
• Report Number: 2124215-2024-70976
• Device Sequence Number: 15676910
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2026
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0034391564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 11/15/2024
• Date Device Manufactured: 07/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown