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

Model Number 10445

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/06/2023

Event Type  malfunction  

Event Description

It was reported that foreign object embolized inside patient.A transcatheter aortic valve replacement procedure was being performed utilizing a 14f isleeve introducer sheath and a non-boston scientific (bsc) aortic valve system (comprised of a delivery system and 29mm valve).The 14f isleeve was prepared per the instructions for use and was inserted without issue.A 20mm non-bsc balloon catheter was advanced through the 14f isleeve for balloon aortic valvuloplasty (bav).The 29mm non-bsc aortic valve system was advanced through the 14f isleeve and to the native aortic annulus.Under fluoroscopy, when crossing the native aortic annulus with the 29mm non-bsc valve system, a radiopaque foreign object was identified attached just above the nose cone on the shaft of the non-bsc delivery system.Since the 29mm non-bsc valve was already across the native aortic annulus, the foreign object was sub annular in the left ventricular outflow tract.During initial deployment of the 29mm non-bsc valve, the foreign object dislodged and moved into the left ventricle.The physicians believe the patient had an undiagnosed ventricular septal defect (vsd) which allowed the foreign object to pass into the right ventricle cavity and was ejected into the pulmonary vasculature.The foreign object remained lodged in the pulmonary vasculature.Under fluoroscopy, the foreign object appeared small, rectangular, and thin.The 29mm non-bsc valve was successfully deployed in the intended location.The non-bsc delivery system and the 14f isleeve were removed and inspected.The physicians suspect the radiopaque foreign object could be a segment of the radiopaque isleeve marker.Due to the position, the physicians were unable to snare the foreign object, thus it remains unretrieved in the pulmonary vasculature.The patient remained stable throughout, showing no signs of acute pulmonary event.The patient has been discharged.

Manufacturer Narrative

H6: device code corrected from 'material integrity problem' to 'detachment or device or device component' h6: evaluation conclusion code updated from 'conclusion not yet available' to 'failure to follow instructions'.Device and media evaluated by mfr: the 14f isleeve introducer sheath was returned for analysis and analyzed by a bsc quality technician.Initial inspection revealed the 14f isleeve introducer sheath was returned with the dilator completely pushed into/through the 14f isleeve introducer sheath and out of the 14f isleeve introducer sheath tip.Blood was noted inside and on the outside of the 14f isleeve introducer sheath.Further inspection revealed the 14f isleeve introducer sheath tip was torn at the seam and a portion of the tip was torn off.The torn tip occurred along the seam line.The 14f isleeve introducer sheath tip is designed to expand and tear with use to allow for passage of the acurate valve system and ancillary devices used during the transcatheter aortic valve replacement procedures.Device analysis confirmed the reported damage.Pre-procedural planning computed tomography (ct) imaging was provided to aid in the investigation and was reviewed by a bsc medical director.The pre-procedural ct was not available to assess the vascular access dimensions.Procedural angiographic media was provided to aid in the investigation and was reviewed by a bsc medical director.The media showed that when the non-bsc valve was positioned in the native aortic annulus, a radiopaque image was seen in the nosecone of the non-bsc delivery system.As the non-bsc valve initiated deployment, the foreign object moved out of the nosecone and freely moved in what could be topography of either left atrium or right ventricle.The two-dimensional nature of the angiogram precluded proper interpretation of the anatomical place the foreign object was positioned.Post-implant of the non-bsc valve, the radiopaque foreign object moved further.On the final images, it appeared the foreign object followed the lung movements with inspiration/expiration, indicating it was likely located in the pulmonary vasculature, which would indicate it somehow moved from the left heart to the right.Possibilities would include intraventricular communication.Photographic images and video of the 14f isleeve introducer sheath after use were provided to aid in the investigation and reviewed by a bsc quality techician and a bsc medical director.The photographic images and video showed the tip of the 14f isleeve introducer sheath with a portion detached.The missing part appeared to correlate to the radiopaque foreign object observed in the angiographic images.The returned device analysis confirmed a portion of the 14f isleeve introducer sheath tip was torn off which matched the missing part in the images and correlated to the radiopaque foreign object observed in the angiographic images.The 14f isleeve introducer sheath was used with a non-acurate tf valve system.Based on the available information, it is reasonable to assume that the non-bsc delivery system snagged the tip of the 14f isleeve introducer sheath, tearing it free.

Event Description

It was reported that a portion of the 14f isleeve introducer sheath detached and was left in the patient.A transcatheter aortic valve replacement procedure was being performed utilizing a 14f isleeve introducer sheath and a non-boston scientific (bsc) aortic valve system (comprised of a delivery system and 29mm valve).The 14f isleeve introducer sheath was prepared per the instructions for use and was inserted without issue.A 20mm non-bsc balloon catheter was advanced through the 14f isleeve introducer sheath for balloon aortic valvuloplasty (bav).The 29mm non-bsc aortic valve system was advanced through the 14f isleeve introducer sheath and to the native aortic annulus.Under fluoroscopy, when crossing the native aortic annulus with the 29mm non-bsc valve system, a radiopaque foreign object was identified attached just above the nose cone on the shaft of the non-bsc delivery system.Since the 29mm non-bsc valve was already across the native aortic annulus, the foreign object was sub annular in the left ventricular outflow tract.During initial deployment of the 29mm non-bsc valve, the foreign object dislodged and moved into the left ventricle.The physicians believe the patient had an undiagnosed ventricular septal defect (vsd) which allowed the foreign object to pass into the right ventricle cavity and was ejected into the pulmonary vasculature.The foreign object remained lodged in the pulmonary vasculature.Under fluoroscopy, the foreign object appeared small, rectangular, and thin.The 29mm non-bsc valve was successfully deployed in the intended location.The non-bsc delivery system and the 14f isleeve introducer sheath were removed and inspected.The physicians suspect the radiopaque foreign object could be a segment of the radiopaque 14f isleeve introducer sheath marker.Due to the position, the physicians were unable to snare the foreign object, thus it remains unretrieved in the pulmonary vasculature.The patient remained stable throughout, showing no signs of acute pulmonary event.The patient has been discharged.

• 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: 18428044
• MDR Text Key: 331918037
• Report Number: 2124215-2023-70161
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 08714729950660
• UDI-Public: 08714729950660
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/18/2024

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: 0032331162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 03/06/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1