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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 10604
Medical Device Problem Codes Entrapment of Device (1212); Failure to Advance (2524)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/10/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device is a combination product.
 
Event or Problem Description
It was reported that device entrapment occurred.A 2.75 x 24 synergy drug-eluting stent was advanced but failed to cross the lesion.The device was stuck on the non bsc guidewire and would not detach.The device was simply removed as a whole from the patient's body.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
 
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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 Key8256382
Report Number2134265-2018-65155
Device Sequence Number13933446
Product Code NIQ
UDI-Device Identifier08714729840220
UDI-Public08714729840220
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P150003
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 01/17/2019
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 Date09/03/2020
Device Model Number10604
Device Catalogue Number10604
Device Lot Number0022658742
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/21/2018
Initial Report FDA Received Date01/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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