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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 10622
Device Problems Leak/Splash (1354); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2023
Event Type  malfunction  
Event Description
It was reported that a shaft hole occurred.The significant target lesion was located in the mid-right coronary artery.A 3.00 x 32 synergy drug-eluting stent (des) was selected for treatment.During preparation, while applying negative pressure, it was noted that the inflation device was sucking air that was coming out of the shaft proximal to the monorail port.Additionally, a kink on the shaft of the stent was observed where air was coming through.The procedure was completed with another of same device.No patient complications were reported.
 
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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 Key18047439
MDR Text Key327065804
Report Number2124215-2023-57015
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeSF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 11/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10622
Device Catalogue Number10622
Device Lot Number0030178426
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/11/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/05/2022
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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