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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 H7493942812500
Device Problems Deflation Problem (1149); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: the date of the event is unknown. Boston scientific became aware of the event on 30 june 2021. There a date of (b)(6) 2021 was entered to indicate that the event occurred on an unknown day in (b)(6) 2021.
 
Event Description
It was reported that failure to deflate a balloon and balloon damage occurred. A 5. 00 x 12mm synergy megatron was used for treatment, but the balloon on the stent would not deflate. It was noted that when the balloon was inspected, it appeared to be mangled. The procedure was completed and no patient complications resulted in relation to this event.
 
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Brand NameSYNERGY MEGATRON
Type of DeviceCORONARY 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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12191342
MDR Text Key262434351
Report Number2134265-2021-09126
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/07/2021
Device Model NumberH7493942812500
Device Lot Number0026533870
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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