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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XXL ESOPHAGEAL; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC CORPORATION XXL ESOPHAGEAL; DILATOR, ESOPHAGEAL Back to Search Results
Model Number 23375
Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/08/2019
Event Type  malfunction  
Manufacturer Narrative
Age at the time of event: 50 's or 60's.
 
Event Description
It was reported that balloon rupture and detachment occurred.The 40-50% stenosed target lesion was located in the mildly tortuous ostium of the left iliac vein.A 18-6/5.8/75 xxl esophageal balloon catheter was advanced for dilatation.However, during first inflation at 5 atmospheres, the balloon ruptured and was removed.A 16-6/5.8/75 xxl esophageal balloon catheter was then used.The balloon was able to dilate three areas at 45 atmospheres each; however, on the fourth area, pressure was lost on the inflation device.When the device was removed, it was noticed that the balloon material was wrecked and not intact.All pieces were successfully removed from the patient's body and a second 16x6 xxl esophageal balloon catheter was inflated two more times and the procedure was completed.No patient complications were reported.
 
Event Description
It was reported that balloon rupture and detachment occurred.The 40-50% stenosed target lesion was located in the mildly tortuous ostium of the left iliac vein.A 18-6/5.8/75 xxl esophageal balloon catheter was advanced for dilatation.However, during first inflation at 5 atmospheres, the balloon ruptured and was removed.A 16-6/5.8/75 xxl esophageal balloon catheter was then used.The balloon was able to dilate three areas at 45 atmospheres each; however, on the fourth area, pressure was lost on the inflation device.When the device was removed, it was noticed that the balloon material was wrecked and not intact.All pieces were successfully removed from the patient's body and a second 16x6 xxl esophageal balloon catheter was inflated two more times and the procedure was completed.No patient complications were reported.
 
Manufacturer Narrative
Age at the time of event - 50 's or 60's.Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that a complete circumferential tear was present in the balloon.The tear was located approximately 10 cm distal from the proximal edge of the proximal balloon sleeve.The distal section of the balloon tear was pulled over the tip of the device.A visual and microscopic examination was performed on the balloon material returned and no issues were noted with the balloon material that could have contributed to the damage identified.A visual and tactile examination of the returned device identified no issues with the shaft.A visual and microscopic examination identified no damage to the tip.No other issues were identified during the product analysis.
 
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Brand Name
XXL ESOPHAGEAL
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8836465
MDR Text Key152518547
Report Number2134265-2019-08288
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier08714729163114
UDI-Public08714729163114
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/24/2022
Device Model Number23375
Device Catalogue Number23375
Device Lot Number0023538860
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2019
Date Manufacturer Received07/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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