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

Model Number 10445

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/27/2024

Event Type  malfunction  

Event Description

It was reported that the tip tore in an atypical manner.Procedure summary a 14f isleeve introducer sheath was used to successfully complete a transcatheter aortic valve replacement (tavr) procedure.The procedure was performed as a single access procedure using the 14f isleeve introducer sheath to introduce the loaded valve delivery system and also to introduce the pigtail through the hemostatic valve.The physician made a second puncture at around the 3 o'clock mark on the hemostatic valve to introduce a 5fr pigtail.The physicians were aware that the use was considered off label use of the 14f isleeve introducer sheath as a single access device for both delivery system and secondary pigtail.After the removal of the 14f isleeve introducer sheath, the physician noted that the tip of the 14f isleeve introducer sheath had tore in an atypical manner nearly detaching from the 14f isleeve introducer sheath.Patient status: no patient consequences were reported.

Manufacturer Narrative

Device evaluated by mfr.: a 14f isleeve sheath with the dilator was returned for analysis and evaluated by bsc engineers.The dilator was not received inside the 14f isleeve sheath.Visual and microscopic investigation of the 14f isleeve found blood was present on the outside of the 14f isleeve sheath and inside of the hub.All three (3) seams of the14f isleeve were expanded with the tip torn at one of the seams.The expanded seams of the 14f isleeve occurred along the seam line and is expected as the seams and tip are designed to expand with use to allow passage of delivery system and bav during the procedure; therefore, this is not considered damage to the device.The tip was also lifted and partially torn, but still attached at the distal end of the tip.There were numerous kinks throughout the 14f isleeve sheath.It was confirmed that two of the seals had damage.A photograph was provided to aid in the investigation and was reviewed by bsc engineers.The photograph showed that portion of the 14f isleeve tip was lifted and partially detached.The damage to the tip matches the damage to the returned device.

Event Description

It was reported that the tip tore in an atypical manner.Procedure summary: a 14f isleeve introducer sheath was used to successfully complete a transcatheter aortic valve replacement (tavr) procedure.The procedure was performed as a single access procedure using the 14f isleeve introducer sheath to introduce the loaded valve delivery system and also to introduce the pigtail through the hemostatic valve.The physician made a second puncture at around the 3 o'clock mark on the hemostatic valve to introduce a 5fr pigtail.The physicians were aware that the use was considered off label use of the 14f isleeve introducer sheath as a single access device for both delivery system and secondary pigtail.After the removal of the 14f isleeve introducer sheath, the physician noted that the tip of the 14f isleeve introducer sheath had tore in an atypical manner nearly detaching from the 14f isleeve introducer sheath.Patient status: no patient consequences were reported.

• Brand Name: ISLEEVE 14F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18904574
• MDR Text Key: 337671255
• Report Number: 2124215-2024-13150
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0032642611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1