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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 Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2023
Event Type  malfunction  
Event Description
It was reported that leakage on the balloon occurred.A 16-4/5.8/75 xxl balloon dilator was selected for treatment for may thurner.Above 80 compression was noted in the common iliac vein and an 18x90 wallstent device was placed.When the balloon was inserted, there was negative pressure pulled with the indeflator and blood was coming back to it.The device was removed and replaced with another of the same model to complete the procedure.No complications were reported, and the patient was in a stable condition.
 
Event Description
It was reported that leakage on the balloon occurred.A 16-4/5.8/75 xxl balloon dilator was selected for treatment for may thurner.Above 80 compression was noted in the common iliac vein and an 18x90 wallstent device was placed.When the balloon was inserted, there was negative pressure pulled with the indeflator and blood was coming back to it.The device was removed and replaced with another of the same model to complete the procedure.No complications were reported, and the patient was in a stable condition.
 
Manufacturer Narrative
Device eval by mfr: the device was returned, and analysis completed.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was observed inside the balloon which is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 4mm distal of the proximal balloon bond.A visual and tactile examination identified no kinks or damage to the shaft of the device.A visual examination identified no issues with the tip of the device.
 
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Brand Name
XXL ESOPHAGEAL
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18466324
MDR Text Key332909486
Report Number2124215-2023-75281
Device Sequence Number1
Product Code KNQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number23375
Device Catalogue Number23375
Device Lot Number0031396893
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/16/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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