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

Model Number 10445

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2022

Event Type  malfunction  

Event Description

It was reported that failure to advance the introducer sheath within the artery occurred.Procedure summary the moderately calcified native aortic annulus was 21.7mm in diameter.Vascular access was obtained via a transfemoral approach.The access vessel was mildly tortuous with calcifications noted in the common iliac artery.A 14f isleeve introducer sheath was advanced to the bifurcation of the common iliac arteries and could not be advanced further due to circular calcifications in the abdominal aorta.An extra small (xs) safari2 guidewire was positioned.Balloon aortic valvuloplasty was performed with a 20mm non-boston scientific balloon catheter in accordance with the instructions for use (ifu).A size small 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 inserted but was not able to advance due to calcifications in the right common iliac artery.Contralateral access was obtained.The physician attempted unsuccessfully to dilate the vessel from the contralateral side to break up the calcifications in the vessel.The 14f isleeve was removed first, followed by the acurate neo2 tf ds.A vessel dissection was noted that was attributed to free cell protrusion on the acurate neo2 valve.A balloon catheter was placed above the dissection to stop the bleeding.The patient went into cardiac arrest, cardiopulmonary resuscitation was performed; however the patient condition did not improve.Patient status the patient died.

Manufacturer Narrative

H3: device eval by manufacturer: returned product consisted of the 14f isleeve introducer sheath with blood on/in the 14f isleeve introducer sheath.There were numerous kinks on the 14f isleeve introducer sheath.The 14f isleeve introducer sheath was buckled 14cm-16cm distal of the strain relief.All three seams of the 14f isleeve introducer sheath were found to be expanded, consistent with device usage as designed.The tip of the 14f isleeve introducer sheath was torn at the seams and damaged.Product analysis could not confirm the reported difficulty to advance, as the clinical circumstances were not able to be replicated.The damage to the 14f isleeve device is consistent with difficulty experienced during the procedure.

Event Description

It was reported that failure to advance the introducer sheath within the artery occurred.Procedure summary: the moderately calcified native aortic annulus was 21.7mm in diameter.Vascular access was obtained via a transfemoral approach.The access vessel was mildly tortuous with calcifications noted in the common iliac artery.A 14f isleeve introducer sheath was advanced to the bifurcation of the common iliac arteries and could not be advanced further due to circular calcifications in the abdominal aorta.An extra small (xs) safari2 guidewire was positioned.Balloon aortic valvuloplasty was performed with a 20mm non-boston scientific balloon catheter in accordance with the instructions for use (ifu).A size small 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 inserted but was not able to advance due to calcifications in the right common iliac artery.Contralateral access was obtained.The physician attempted unsuccessfully to dilate the vessel from the contralateral side to break up the calcifications in the vessel.The physician elected to retract the acurate neo2 tf ds through the 14 f isleeve introducer sheath.A vessel dissection was noted that was attributed to free cell protrusion on the acurate neo2 valve.A balloon catheter was placed above the dissection to stop the bleeding.The patient went into cardiac arrest, cardiopulmonary resuscitation was performed; however, the patient condition did not improve.Patient status: the patient died.It was further reported that the 14f isleeve was removed first, followed by the acurate neo2 tf ds.

• 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: 15668378
• MDR Text Key: 307167098
• Report Number: 2124215-2022-43432
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• 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: 0029846195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Female