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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 10620
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 04/16/2019
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that blood was attached to the plastic package.During unpacking of a 3.00 x 24mm synergy ii drug eluting stent, it was noticed that blood was found adhered to the plastic package in 1cm size.No tear was observed in the inner pouch.No complications were reported.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8595109
MDR Text Key144569946
Report Number2134265-2019-05030
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other
Type of Report Initial
Report Date 05/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/28/2020
Device Model Number10620
Device Catalogue Number10620
Device Lot Number0023305474
Was Device Available for Evaluation? No
Date Manufacturer Received04/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2019
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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