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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 10602
Medical Device Problem Code Deflation Problem (1149)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/12/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that deflation failure occurred.A 4.00 x 16 synergy ii drug-eluting stent was advanced for treatment.After the stent was implanted, several unsuccessful attempts were made to deflate the balloon.The guide was negative and the inflation device was pulled negative several times.The partially deflated balloon was removed together with the guide catheter and the guidewire.No patient complications were reported.
 
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Brand Name
SYNERGY
Common Device Name
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11638927
Report Number2134265-2021-03830
Device Sequence Number3159980
Product Code NIQ
UDI-Device Identifier08714729840138
UDI-Public08714729840138
Combination Product (Y/N)Y
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
P150003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date10/12/2022
Device Model Number10602
Device Catalogue Number10602
Device Lot Number0026193986
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/17/2021
Initial Report FDA Received Date04/08/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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