MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XXL VASCULAR; DILATOR, ESOPHAGEAL

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Internal Organ Perforation (1987); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

Mw5090530.

Event Description

It was reported via medwatch mw5090530 that tip detachment and organ perforation occurred.The patient presented with symptomatic pelvic vein compression.The target lesion was located in the right common iliac vein and proximal external iliac vein.After implanting a 14x100mm non-bsc venous stent, a 14mm x 60mm xxl balloon catheter was advanced for dilatation.After venoplasty was completed, the balloon was deflated.As the device was being pulled into the sheath, without resistance, it was noted that the distal tip had detached at the proximal end of the balloon portion and had traveled to the pulmonary artery.A 7f snare was able to retrieve most of the detached piece, however, a small fragment of the balloon remained within the right internal jugular vein at the access site extending into the soft tissues of the right supraclavicular area.After several failed attempts to remove the remaining fragment, the patient was sent, in stable condition, via emergency medical services to a hospital where a vascular surgeon could remove the fragment.On follow-up with relatives, it was reported that there was a perforation of the heart presumably related to the passage of the catheter fragment through the right atrium.

Event Description

It was reported via medwatch mw5090530 that tip detachment and organ perforation occurred.The patient presented with symptomatic pelvic vein compression.The target lesion was located in the right common iliac vein and proximal external iliac vein.After implanting a 14x100mm non-bsc venous stent, a 14mm x 60mm xxl balloon catheter was advanced for dilitation.After venoplasty was completed, the balloon was deflated.As the device was being pulled into the sheath, without resistance, it was noted that the distal tip had detached at the proximal end of the balloon portion and had traveled to the pulmonary artery.A 7f snare was able to retrieve most of the detached piece, however, a small fragment of the balloon remained within the right internal jugular vein at the access site extending into the soft tissues of the right supraclavicular area.After several failed attempts to remove the remaining fragment, the patient was sent, in stable condition, via emergency medical services to a hospital where a vascular surgeon could remove the fragment.On follow-up with relatives, it was reported that there was a perforation of the heart presumably related to the passage of the catheter fragment through the right atrium.It was further reported that this event is a duplicate reporting of emdr 2134265-2019-12211.

• Brand Name: XXL VASCULAR
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9377698
• MDR Text Key: 168068686
• Report Number: 2134265-2019-14487
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention