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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 Material Rupture (1546)
Patient Problem Insufficient Information (4580)
Event Date 02/24/2021
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The target lesion was located in the left common iliac vein.A 14-4/5.8/75 xxl vascular balloon catheter was introduced for 2-3 inflations and removed.When the balloon was reinserted to post-dilate a wallstent, the balloon ruptured when inflated at 8 atmospheres for a minute and a half to two minutes.The device was completely removed and a 14-6/5.8/75 xxl vascular balloon catheter was introduced to post dilate the stent.Inflations were completed and injection was done.When the balloon was reinserted for another dilation, it also ruptured when inflated at 8 atmospheres for a minute and a half to two minutes.The device was removed and the procedure was completed.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr: a xxl/14-4/5.8/75 was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was present in the balloon which is indicative of a leak.The balloon was attached to an encore inflation device, subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located 2mm distal from the distal tip.An examination of the balloon material and the tip region identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 8 atmospheres as per xxl specification.A visual and tactile examination identified no damage or issues with the shaft of the device.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.
 
Event Description
It was reported that balloon rupture occurred.The target lesion was located in the left common iliac vein.A 14-4/5.8/75 xxl vascular balloon catheter was introduced for 2-3 inflations and removed.When the balloon was reinserted to post-dilate a wallstent, the balloon ruptured when inflated at 8 atmospheres for a minute and a half to two minutes.The device was completely removed and a 14-6/5.8/75 xxl vascular balloon catheter was introduced to post dilate the stent.Inflations were completed and injection was done.When the balloon was reinserted for another dilation, it also ruptured when inflated at 8 atmospheres for a minute and a half to two minutes.The device was removed and the procedure was completed.There were no patient complications reported.
 
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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 Key11490458
MDR Text Key240057428
Report Number2134265-2021-02929
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729190462
UDI-Public08714729190462
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
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/11/2023
Device Model Number23375
Device Catalogue Number23375
Device Lot Number0026504017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2021
Date Manufacturer Received03/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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