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

Model Number 10445

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/27/2020

Event Type  Injury  

Event Description

It was reported that tip detachment occurred.The patient had very calcified vessels.A 14f isleeve introducer sheath was inserted with no resistance noted.Pre-dilatation was performed with a non-bsc balloon catheter in accordance with the instructions for use (ifu).An acurate neo2 valve was advanced through the 14f isleeve introducer sheath and was successfully implanted.The acurate neo2 delivery system was removed without issue.Post dilatation was performed with a non-bsc balloon catheter in accordance with the ifu.The 14f isleeve was removed from the patient with no resistance noted.After removal of the 14f isleeve introducer sheath from the patient, it was noted on fluoroscopy that a detached fragment of the radiopaque isleeve introducer sheath tip was lodged outside of the vessel.The device fragment was left in the patient.At the time of reporting there were no patient complications, the patient is fine and has been discharged.

Manufacturer Narrative

H3: device eval by manufacturer: the 14f isleeve was returned to boston scientific(bsc) and analyzed by a bsc quality engineer.The returned product consisted of a 14f isleeve catheter and photos.Analysis of the photos, isleeve tip, and isleeve sheath included microscopic and visual inspection.The supplied photo showed a small portion of the tip in the anatomy.Analysis revealed the device tip (seam opened) had a small section missing, sheath kinks located 10.5cm, 13.5cm, and 15cm from the tip, sheath damage (abrasions/crazing).2 of the 3 seams were partially opened.Inspection of the rest of the device found no other damage or defect.The reported tip separation was confirmed.

Event Description

It was reported that tip detachment occurred.The patient had very calcified vessels.A 14f isleeve introducer sheath was inserted with no resistance noted.Pre-dilatation was performed with a non-bsc balloon catheter in accordance with the instructions for use (ifu).An acurate neo2 valve was advanced through the 14f isleeve introducer sheath and was successfully implanted.The acurate neo2 delivery system was removed without issue.Post dilatation was performed with a non-bsc balloon catheter in accordance with the ifu.The 14f isleeve was removed from the patient with no resistance noted.After removal of the 14f isleeve introducer sheath from the patient, it was noted on fluoroscopy that a detached fragment of the radiopaque isleeve introducer sheath tip was lodged outside of the vessel.The device fragment was left in the patient.At the time of reporting there were no patient complications, the patient is fine and has been discharged.

• 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: 10836625
• MDR Text Key: 216136119
• Report Number: 2134265-2020-15642
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2022
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0025319316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Date Manufacturer Received: 11/24/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other