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

Model Number 10445

Device Problems Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

Event Type  Injury  

Event Description

It was reported that tip detachment occurred.The patient had mild tortuosity and mild calcification.Vascular access was obtained via a transfemoral approach and a 14f isleeve introducer sheath was placed.Balloon aortic valvuloplasty (bav) was performed with a non-boston scientific balloon catheter.An acurate neo2 valve delivery system was then inserted and advanced.During advancement of the acurate neo2 valve delivery system, near the abdominal aorta, a round tubular particle, believed to be a fragment from the 14f isleeve introducer sheath tip was observed to be in front of the acurate neo2 delivery system tip.No resistance was encountered while advancing the acurate neo2 valve delivery system.The physician continued with the procedure and successfully implanted the acurate neo2 valve.The 14f isleeve introducer sheath tip fragment was observed to be close to the upper crown of the acurate neo2 valve.During removal of the acurate neo2 delivery system, the physician used the pigtail catheter to move the guidewire towards the 14f isleeve introducer sheath tip fragment and trap it.A 10mm snare was then used to move the 14f isleeve introducer sheath tip fragment into the 14f isleeve introducer sheath.The 14f isleeve introducer and tip fragment were removed from the patient successfully.There were no reported patient consequences.

Event Description

It was reported that tip detachment occurred.The patient had mild tortuosity and mild calcification.Vascular access was obtained via a transfemoral approach and a 14f isleeve introducer sheath was placed.Balloon aortic valvuloplasty (bav) was performed with a non-boston scientific balloon catheter.An acurate neo2 valve delivery system was then inserted and advanced.During advancement of the acurate neo2 valve delivery system, near the abdominal aorta, a round tubular particle, believed to be a fragment from the 14f isleeve introducer sheath tip was observed to be in front of the acurate neo2 delivery system tip.No resistance was encountered while advancing the acurate neo2 valve delivery system.The physician continued with the procedure and successfully implanted the acurate neo2 valve.The 14f isleeve introducer sheath tip fragment was observed to be close to the upper crown of the acurate neo2 valve.During removal of the acurate neo2 delivery system, the physician used the pigtail catheter to move the guidewire towards the 14f isleeve introducer sheath tip fragment and trap it.A 10mm snare was then used to move the 14f isleeve introducer sheath tip fragment into the 14f isleeve introducer sheath.The 14f isleeve introducer and tip fragment were removed from the patient successfully.There were no reported patient consequences.

Manufacturer Narrative

H3 device eval by manufacturer: returned product consisted of the 14f isleeve introducer sheath, along with a piece of foreign material (fm) that was analyzed by a bsc quality engineer.The device was bloody, and the dilator was inside the sheath.The customer also supplied photos of the device and the reported fm.Analysis of the fm, tip, sheath and hub/valve included microscopic and visual inspection.Inspection revealed tip damage (abrasions/misshapen), and sheath damage (flattened).Two of the three perforations were partially opened.Inspection of the rest of the device found no other damage or defects, and the device was not separated.Inspection of the fm included visual, microscopic and dimensional inspection.The fm had the visual of appearance of an isleeve tip prior to being reflowed.The fm was measured and all measurements were approximate as the fm was slightly odd shaped.The fm is consistent with an isleeve tip component.The reported material separation was not confirmed.

• Brand Name: ISLEEVE 14F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11232886
• MDR Text Key: 228845770
• Report Number: 2134265-2021-00603
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2022
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0026052469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention