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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON CORONARY DRUG-ELUTING STENT

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BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493942828500
Device Problems Deflation Problem (1149); Activation, Positioning or Separation Problem (2906)
Patient Problem Obstruction/Occlusion (2422)
Event Date 06/28/2021
Event Type  malfunction  
Event Description
Megatron stent delivery system (sds) balloon deployed from megatron rx 5x28mm stent and would not completely deflate despite multiple attempts. Gentle retraction of the balloon despite double deflation would not remove balloon from stent. The sds balloon then detached from the sds wire, leaving the balloon occluding the vessel. Balloon able to be retrieved with a snare after patient was re-stabilized.
 
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Brand NameSYNERGY MEGATRON
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12120450
MDR Text Key260021680
Report Number12120450
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH7493942828500
Device Catalogue NumberH7493942828500
Device Lot Number26502747
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/29/2021
Event Location Hospital
Date Report to Manufacturer07/06/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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