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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
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: event date was not provided at the time of reporting.The first date of the month of the aware date was selected.
 
Event Description
It was reported that the sterile pouch seal was compromised.A 5.00 x 16mm synergy megatron coronary drug-eluting stent product pouch was observed to be torn during preparation of a procedure.The synergy megatron was not used.The procedure was completed with a non-bsc device.No patient complications occurred as a result of the event.
 
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Brand Name
SYNERGY MEGATRON
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15349230
MDR Text Key303563453
Report Number2124215-2022-32743
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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