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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 Material Rupture (1546)
Patient Problem Insufficient Information (4580)
Event Date 05/19/2021
Event Type  malfunction  
Event Description
It was reported that a balloon rupture occurred.During a procedure, a 4.00 x 48 synergy ii drug eluting stent was used, but before positioning the device onto the guide and without inadvertent manipulation of the device, a rupture of the body of the balloon occurred.No patient complications were reported in relation to this event.
 
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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 CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11894825
MDR Text Key252961175
Report Number2134265-2021-06910
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/13/2022
Device Model Number10632
Device Catalogue Number10632
Device Lot Number0026237653
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/13/2020
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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