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

Model Number	10445
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that atypical tip damage occurred.The patient's femoral anatomy contained moderate calcium, stenosis, and tortuosity.A transcatheter aortic valve replacement procedure was being performed, utilizing a 14f isleeve introducer sheath for femoral access.A 14f isleeve introducer sheath was placed, then balloon aortic valvuloplasty (bav) was performed with a 25mm non-boston scientific (bsc) balloon catheter.During withdraw of the 25mm non-bsc balloon catheter, resistance was noted but the balloon was successfully removed.A size large 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 and the acurate neo2 valve was implanted successfully.Upon removal of the 14f isleeve introducer sheath from the patient's anatomy, the radio-opaque tip was noted to have more tearing than typical with a noticeable flap.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr.: the 14f isleeve introducer sheath was returned for device analysis.The 14f isleeve introducer sheath was returned along with the dilator not inside the sheath and with the tip inserted into a styrofoam block.Visual and microscopic inspection identified all three seams to be expanded, and the tip was split.The expanded seams and split tip of the 14f isleeve introducer sheath occurred along the seam line and is expected with use as the seams are designed to expand and the tip to split with use to allow passage of delivery system and balloon aortic valvuloplasty during the procedure; therefore, this is not considered damage to the device.Visual and microscopic analysis also identified numerous kinks in the sheath, the tip was damaged and partially torn (not at the split seam).The difficulty to remove ancillary device was not able to be confirmed as the clinical circumstances could not be replicated.However, the damage observed upon analysis was most likely caused by the reported difficulty and it is possible to conclude that interaction with an ancillary device could have contributed to the damage.Two photos were provided to aid in the investigation and reviewed by a bsc quality technician.The photos showed the 14f isleeve introducer sheath to be kinked and the tip damaged, consistent with the damage observed upon device analysis.
Event or Problem Description
It was reported that atypical tip damage occurred.The patient's femoral anatomy contained moderate calcium, stenosis, and tortuosity.A transcatheter aortic valve replacement procedure was being performed, utilizing a 14f isleeve introducer sheath for femoral access.A 14f isleeve introducer sheath was placed, then balloon aortic valvuloplasty (bav) was performed with a 25mm non-boston scientific (bsc) balloon catheter.During withdraw of the 25mm non-bsc balloon catheter, resistance was noted but the balloon was successfully removed.A size large 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 and the acurate neo2 valve was implanted successfully.Upon removal of the 14f isleeve introducer sheath from the patient's anatomy, the radio-opaque tip was noted to have more tearing than typical with a noticeable flap.There were no patient complications.

• 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: 20239813
• Report Number: 2124215-2024-57173
• Device Sequence Number: 12920999
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/23/2024

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: 07/26/2026
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0034517472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown