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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENCORE 26 ADVANTAGE KIT; SYRINGE, BALLOON INFLATION
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BOSTON SCIENTIFIC CORPORATION ENCORE 26 ADVANTAGE KIT; SYRINGE, BALLOON INFLATION Back to Search Results
Model Number 2760
Device Problem Failure to Zero (1683)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/27/2022
Event Type  malfunction  
Event Description
It was reported that the pressure did not return to the initial pressure (0 atm).An encore 26 advantage kit was selected for use.During the procedure, the device was inflated at 26 atm.Upon deflation, the balloon was in negative pressure, however, the manometer remained at a pressure of 26 atm and did not return to the initial pressure of 0 atm.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The gauge needle was at 24 atm when received.A non-transparent fluid (whitish) and thick was observed inside the syringe and in the flexing tube.Complete functional testing was not possible due to the obstruction in the flexing tube.A hard density material was observed inside the flexing tube & syringe upon x-ray inspection.
 
Event Description
It was reported that the pressure did not return to the initial pressure (0 atm).An encore 26 advantage kit was selected for use.During the procedure, the device was inflated at 26 atm.Upon deflation, the balloon was in negative pressure, however, the manometer remained at a pressure of 26 atm and did not return to the initial pressure of 0 atm.No patient complications were reported.
 
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Brand Name
ENCORE 26 ADVANTAGE KIT
Type of Device
SYRINGE, BALLOON INFLATION
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
model farm road
cork
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15160282
MDR Text Key297230951
Report Number2124215-2022-28681
Device Sequence Number1
Product Code MAV
UDI-Device Identifier08714729180005
UDI-Public08714729180005
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K140745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/10/2024
Device Model Number2760
Device Catalogue Number2760
Device Lot Number0028652876
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2022
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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