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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 9530
Device Problem Contamination (1120)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/24/2019
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that the device was contaminated.An 8x2.25mm synergy drug-eluting stent was selected for treatment.However, the device was contaminated during use.
 
Event Description
It was reported that the device was contaminated.An 8x2.25mm synergy drug-eluting stent was selected for treatment.However, the device was contaminated during use.It was further reported that this event was reported in error.The complaint reporter misread the reported information.The reported event of accidental de-sterilization does not meet complaint criteria and is considered accidental damage.Therefore, this incident no longer meets reporting criteria.
 
Manufacturer Narrative
Device is a combination product.
 
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Brand Name
SYNERGY
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8623249
MDR Text Key145487082
Report Number2134265-2019-05339
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9530
Device Catalogue Number9530
Was Device Available for Evaluation? No
Date Manufacturer Received05/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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