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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 10620
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/19/2024
Event Type  malfunction  
Event Description
It was reported that a balloon inflation issue occurred.A 3.00 x 24 stent balloon expandable stent was selected to treat a lesion located in the left anterior descending artery.During pulmonary vein isolation, the balloon deflated three seconds after inflating.The procedure was completed with a replacement device.No patient complications were reported, and the patient condition was stable following procedure.
 
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Brand Name
SYNERGY
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18875949
MDR Text Key337343829
Report Number2124215-2024-13924
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/11/2024
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
Device Operator Health Professional
Device Model Number10620
Device Catalogue Number10620
Device Lot Number0030166247
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/19/2024
Initial Date FDA Received03/11/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/12/2022
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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