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

Model Number 10445

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)

Patient Problem Vascular Dissection (3160)

Event Date 12/19/2019

Event Type  Injury  

Event Description

It was reported that a dissection occurred.A 14f isleeve introducer sheath was inserted for a valve replacement procedure.Balloon angioplasty was performed.During removal, the balloon catheter became stuck at the tip of the isleeve.The tip of the isleeve became bunched up.The isleeve was exchanged for another of the same device and the procedure was completed.A dissection was noted but the patient continued to have good flow and no treatment was performed.

Event Description

It was reported that a dissection occurred.A 14f isleeve introducer sheath was inserted for a valve replacement procedure.Balloon angioplasty was performed.During removal, the balloon catheter became stuck at the tip of the isleeve.The tip of the isleeve became bunched up.The isleeve was exchanged for another of the same device and the procedure was completed.A dissection was noted but the patient continued to have good flow and no treatment was performed.

Manufacturer Narrative

Returned product consisted of an isleeve device that had a non-bsc balloon catheter stuck in the lumen with a non-bsc inflation device connected to the hub of the balloon catheter.Analysis confirmed kinks throughout the isleeve and the seams expanded.The balloon was bunched up on the distal end.Functional testing was attempted to remove the device, however, due to the damage of the devices removal was not possible.The photos were reviewed and it was confirmed that there are numerous sheath kinks/buckles along the sheath.At lease one of the seams is starting to expand as expected with device usage.The damaged bav device is seen inside of the isleeve.

• 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: 9591603
• MDR Text Key: 175099378
• Report Number: 2134265-2019-16716
• 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: 02/11/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2021
• Device Model Number: 10445
• Device Catalogue Number: 10445
• Device Lot Number: 0024615350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/15/2020
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 02/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other