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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 No Consequences Or Impact To Patient (2199)
Event Date 10/31/2019
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The target lesion was located in the left iliac vein.A 14-4/5.8/75 xxl vascular balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with a 14x60 xxl balloon catheter.No patient complications were reported and the patient was fine.
 
Manufacturer Narrative
Device evaluated by mfr.: the device 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 identified within the balloon and inflation lumen which is evidence of a device leak.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 5mm distal of the proximal balloon sleeve.An examination of the balloon material and proximal markerband identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 8 atmospheres.A visual and tactile examination identified no issues with the tip of the device that could have contributed to the complaint incident.No damage or kinks were identified on the shaft of the device.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 iliac vein.A 14-4/5.8/75 xxl vascular balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with a 14x60 xxl balloon catheter.No patient complications were reported and the patient was fine.
 
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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 Key9336651
MDR Text Key173451243
Report Number2134265-2019-13972
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 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/10/2022
Device Model Number23375
Device Catalogue Number23375
Device Lot Number0023933551
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2019
Date Manufacturer Received12/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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