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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XXL VASCULAR; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC CORPORATION XXL VASCULAR; DILATOR, ESOPHAGEAL Back to Search Results
Model Number 23375
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Perforation (2001); No Consequences Or Impact To Patient (2199)
Event Date 10/04/2019
Event Type  Injury  
Event Description
It was reported that balloon detachment occurred.A 14-6/5.8/75 xxl vascular balloon dilator was inserted into the patient via a intrajugular approach and was successfully inflated.However, when the device was removed from the body after deflation, it was noticed that the shaft snapped at the balloon portion.The device was retrieved via the femoral venous access.No patient complications were reported.
 
Event Description
It was reported that balloon detachment occurred.A 14-6/5.8/75 xxl vascular balloon dilator was inserted into the patient via a intrajugular approach and was successfully inflated.However, when the device was removed from the body after deflation, it was noticed that the shaft snapped at the balloon portion.The device was retrieved via the femoral venous access.No patient complications were reported.It was further reported that the patient target lesion was located in the left common iliac vein.The xxl balloon catheter was used to perform venoplasty post non-bsc stent placement.The balloon was completely deflated and upon removal through the right internal jugular vein, it was noted that the proximal aspect of the balloon catheter was retained with the wire in the iliac vein.Left femoral vein access was then obtained for retrieval of the device fragment.The guidewire that was already in place through the right internal jugular vein access to the left common iliac vein was moved inferiorly and introduced through the sheath placed at the left femoral vein.A non-bsc snare was advanced using the guidewire to grasp the balloon catheter at the distal end.While maintained at the right internal jugular vein, the balloon catheter was cut at the hub.The snare was used to guide the distal end of the balloon catheter through the femoral vein access.The device was completely removed in its entirety, confirmed via venogram.The patient was stable post-procedure with no negative sequelae.It was further reported via medwatch mw5090530 that 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 entire distal tip of the catheter 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.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual examination identified a complete circumferential tear of the balloon material located at the proximal balloon bond.The balloon material was pushed distally towards the tip of the device.This type of damage is consistent with excessive force being applied when removing the device from the patient.A visual and tactile examination identified a complete break of the shaft of the device located approximately 55mm distal of the manifold.A microscopic examination found the shaft of the device to have been cut as no stretching of the shaft was found.This type of damage is consistent with the shaft coming into contact with a sharp object.A visual examination found no issues with the markerbands or tip of the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that balloon detachment occurred.A 14-6/5.8/75 xxl vascular balloon dilator was inserted into the patient via a intrajugular approach and was successfully inflated.However, when the device was removed from the body after deflation, it was noticed that the shaft snapped at the balloon portion.The device was retrieved via the femoral venous access.No patient complications were reported.It was further reported that the patient target lesion was located in the left common iliac vein.The xxl balloon catheter was used to perform venoplasty post non-bsc stent placement.The balloon was completely deflated and upon removal through the right internal jugular vein, it was noted that the proximal aspect of the balloon catheter was retained with the wire in the iliac vein.Left femoral vein access was then obtained for retrieval of the device fragment.The guidewire that was already in place through the right internal jugular vein access to the left common iliac vein was moved inferiorly and introduced through the sheath placed at the left femoral vein.A non-bsc snare was advanced using the guidewire to grasp the balloon catheter at the distal end.While maintained at the right internal jugular vein, the balloon catheter was cut at the hub.The snare was used to guide the distal end of the balloon catheter through the femoral vein access.The device was completely removed in its entirety, confirmed via venogram.The patient was stable post-procedure with no negative sequelae.
 
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Brand Name
XXL VASCULAR
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9218733
MDR Text Key163197744
Report Number2134265-2019-12585
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K150303
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number23375
Device Catalogue Number23375
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2019
Date Manufacturer Received11/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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