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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 10632
Device Problem Fracture
Event Date 08/09/2019
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product.

 
Event Description

It was reported that a stent fracture occurred. A 3. 50 x 48 synergy stent was opened from packaging and it was noticed that the device was broken. It was noted that the device was broken before use and that the actual stent was broken. No patient complications were reported in relation to this event.

 
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Brand NameSYNERGY
Type of DeviceCORONARY DRUG-ELUTING STENT
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 Key9082893
Report Number2134265-2019-11347
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/23/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/18/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number10632
Device Catalogue Number10632
Device LOT Number0023450591
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/09/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/18/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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