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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 H7493942824400
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2022
Event Type  malfunction  
Event Description
It was reported that foreign matter was found in the sterile package.Upon opening of a 4.00 x 24mm synergy megatron drug-eluting stent, a hair was found inside the sterile package.The device was not used inside the patient and the procedure was completed successfully with no patient complications reported.
 
Event Description
It was reported that foreign matter was found in the sterile package.Upon opening of a 4.00 x 24mm synergy megatron drug-eluting stent, a hair was found inside the sterile package.The device was not used inside the patient and the procedure was completed successfully with no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr.The device was returned for analysis.Visual inspection showed hair like fibre observed inside sealed pouch approximately 3cm long.
 
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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 Key16051798
MDR Text Key308023003
Report Number2124215-2022-53397
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729985709
UDI-Public08714729985709
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,Followup
Report Date 02/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/06/2023
Device Model NumberH7493942824400
Device Lot Number0028687822
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/13/2022
Initial Date FDA Received12/27/2022
Supplement Dates Manufacturer Received02/10/2023
Supplement Dates FDA Received02/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/06/2022
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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