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 Vascular Dissection (3160)

Event Date 09/05/2022

Event Type  malfunction  

Event Description

It was reported that difficulty removing the delivery system through the introducer sheath and dissection occurred.Procedure summary: vascular access was obtained via a transfemoral approach.The severely calcified native aortic annulus was 21.9mm in diameter and mildly tortuous.A 14f isleeve introducer sheath was advanced into position.Balloon aortic valvuloplasty (bav) was performed with a non-bsc balloon catheter in accordance with the instructions for use (ifu).An acurate neo2 valve was prepared and loaded onto an acurate neo2 transfemoral (tf) delivery system (ds) in accordance with the ifu.The acurate neo2 tf ds was advanced into position.The acurate neo2 valve opened normally with deployment.The acurate neo2 valve was successfully implanted to treat the native aortic annulus.The handle of the acurate neo2 tf ds was turned to prepare the acurate neo2 tf ds for removal from the patient.During withdrawal of the acurate neo2 tf ds, the acurate neo2 tf ds interacted with the tip of the 14f isleeve introducer sheath and the acurate neo2 tf ds was unable to be withdrawn through the 14f isleeve introducer sheath.The physicians turned the handle of the acurate neo2 tf ds to reopen the distal end of the acurate neo2 tf ds in an attempt to free the devices.The physicians turned the handle of the acurate neo2 tf ds again to reclose the acurate neo2 tf ds and were eventually able to successfully remove the acurate neo2 tf ds and isleeve from the patient as a unit.An iliac artery dissection with leakage was noted.Patient status: after an unspecified intervention by the physicians, the patient's condition was stable and there was no need for further intervention by the vascular surgeon.The patient continues to be monitored.

Manufacturer Narrative

Patient year of birth: 1939.

Event Description

It was reported that difficulty removing the delivery system through the introducer sheath and dissection occurred.Procedure summary: vascular access was obtained via a transfemoral approach.The severely calcified native aortic annulus was 21.9mm in diameter and mildly tortuous.A 14f isleeve introducer sheath was advanced into position.Balloon aortic valvuloplasty (bav) was performed with a non-bsc balloon catheter in accordance with the instructions for use (ifu).An acurate neo2 valve was prepared and loaded onto an acurate neo2 transfemoral (tf) delivery system (ds) in accordance with the ifu.The acurate neo2 tf ds was advanced into position.The acurate neo2 valve opened normally with deployment.The acurate neo2 valve was successfully implanted to treat the native aortic annulus.The handle of the acurate neo2 tf ds was turned to prepare the acurate neo2 tf ds for removal from the patient.During withdrawal of the acurate neo2 tf ds, the acurate neo2 tf ds interacted with the tip of the 14f isleeve introducer sheath and the acurate neo2 tf ds was unable to be withdrawn through the 14f isleeve introducer sheath.The physicians turned the handle of the acurate neo2 tf ds to reopen the distal end of the acurate neo2 tf ds in an attempt to free the devices.The physicians turned the handle of the acurate neo2 tf ds again to reclose the acurate neo2 tf ds and were eventually able to successfully remove the acurate neo2 tf ds and isleeve from the patient as a unit.An iliac artery dissection with leakage was noted.Patient status: after an unspecified intervention by the physicians, the patient's condition was stable and there was no need for further intervention by the vascular surgeon.The patient continues to be monitored.It was further reported that the patients condition remained stable and there were no other complications.The patient was discharged from the hospital a week post procedure.

Manufacturer Narrative

H3 device evaluated by mfr: the returned product consisted of the 14f isleeve introducer sheath without the dilator.The cap, sheath, and tip of the 14f isleeve introducer sheath were visually and microscopically examined.Inspection of the isleeve 14f sheath revealed that there was blood inside the isleeve 14f sheath.The isleeve 14f sheath was buckled 13.5cm to 16.5cm and 24cm to 31cm distal of the strain relief.All three of the seams of the 14f isleeve introducer sheath were expanded.The damage to the shaft and tip of the isleeve 14f sheath was consistent with resistance and manipulation while being used in the patient.It was most likely that the tip was damaged and torn upon withdrawal of the acruate neo2 transfemoral delivery system, the acruate neo2 transfemoral delivery system had interacted with the torn part of the isleeve 14f sheath tip.A single angiogram image was provided and was reviewed by a bsc quality engineer.The image showed the acurate neo2 tf ds in the abdominal aorta after the acurate neo2 valve release.The acurate neo2 tf ds had been partially withdrawn into the 14f isleeve introducer sheath with the radiopaque tip of the 14f isleeve introducer sheath appearing to be damaged.

• 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: 15962609
• MDR Text Key: 307795717
• Report Number: 2124215-2022-36232
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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
• Report Date: 12/22/2022

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: 0029830813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 12/08/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female