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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 2800
Device Problem Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Date 03/01/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: the event date was not provided.The first date of the month of the aware date was used.
 
Event Description
It was reported that positive pressure was applied without the device being turned.A 26 encore advantage kit was selected for use.During preparation of a synergy stent, the device was filled with contrast and saline, and the inflation port of the stent was then attached to the inflation device.However, it was noted that the stent continued to inflate at about 3-4atm without being turned.The procedure was then completed with another of the same inflation device and balloon catheter.There were no patient complications reported and the patient's condition was good.
 
Manufacturer Narrative
Date of event: the event date was not provided.The first date of the month of the aware date was used.Device evaluated by mfr.: the device was returned for analysis.Unit returned with its original pouch, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.No visual defects were encountered in the device.A functional test of the complaint device was carried out.The unit passed all functional tests without issues, no leaks nor damages in the device were noted.
 
Event Description
It was reported that positive pressure was applied without the device being turned.A 26 encore advantage kit was selected for use.During preparation of a synergy stent, the device was filled with contrast and saline, and the inflation port of the stent was then attached to the inflation device.However, it was noted that the stent continued to inflate at about 3-4atm without being turned.The procedure was then completed with another of the same inflation device and balloon catheter.There were no patient complications reported and the patient's condition was good.
 
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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
MDR Report Key8455778
MDR Text Key139992635
Report Number2134265-2019-03062
Device Sequence Number1
Product Code MAV
UDI-Device Identifier08714729127048
UDI-Public08714729127048
Combination Product (y/n)N
PMA/PMN Number
K140745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/27/2020
Device Model Number2800
Device Catalogue Number2800
Device Lot Number0022174403
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2019
Date Manufacturer Received04/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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