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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10605
Device Problem Contamination (1120)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2019
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that during a procedure involving a 3.50 x 28 synergy drug-eluting stent, the device was noted to be contaminated.There were no patient complications nor injuries reported.
 
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Brand Name
SYNERGY
Type of Device
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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 Key9378784
MDR Text Key174184466
Report Number2134265-2019-14281
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729840305
UDI-Public08714729840305
Combination Product (y/n)N
PMA/PMN Number
P150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 11/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10605
Device Catalogue Number10605
Device Lot Number0024076305
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2019
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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