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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 10616
Device Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2023
Event Type  malfunction  
Event Description
It was reported that catheter entrapment occurred.The 60% stenosed target lesion was located in the non-tortuous and non-calcified left main artery.A 4.00 x 8 synergy ii drug eluting stent was advanced and deployed for treatment.However, during withdrawal of the non-boston scientific (bsc) guidewire, the stent caught and wrapped over and came out with non-bsc wire.The procedure was completed with alternative method.No patient complications were reported.
 
Manufacturer Narrative
A synergy ous mr 4.00 x 8mm stent delivery system was returned to the complaint investigation site (cis).The stent of the device was returned to the cis for analysis where visual, tactile and microscopic analysis was performed.Device analysis revealed the stent was damaged on its entire length and came attached to a guidewire.The remainder of the device was not returned.
 
Event Description
It was reported that catheter entrapment occurred.The 60% stenosed target lesion was located in the non-tortuous and non-calcified left main artery.A 4.00 x 8 synergy ii drug eluting stent was advanced and deployed for treatment.However, during withdrawal of the non-boston scientific (bsc) guidewire, the stent caught and wrapped over and came out with non-bsc wire.The procedure was completed with alternative method.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
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16599616
MDR Text Key312030852
Report Number2124215-2023-13507
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10616
Device Catalogue Number10616
Device Lot Number0029854324
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/16/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
Patient RaceAsian
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