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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493926020450
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/17/2019
Event Type  malfunction  
Event Description
The 6f guideliner was used during intervention, one synergy stent deployed and then another. The third stent was a 4. 50 x 20 synergy stent. It was loaded on to the guideliner but it wouldn't advance- it would not go through onto the wire. Another stent was used (a 4. 50 x 24) and it went through with no issue. All with excellent results.
 
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Brand NameSYNERGY
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9495538
MDR Text Key172023719
Report Number9495538
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 Other Health Care Professional
Type of Report Initial
Report Date 10/25/2019,10/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH7493926020450
Device Catalogue NumberH7493926020450
Device Lot Number23251600
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/25/2019
Event Location Hospital
Date Report to Manufacturer12/19/2019
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

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