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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY XD; CORONARY DRUG-ELUTING STENT Back to Search Results
Lot Number 0028492645
Device Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/06/2023
Event Type  malfunction  
Event Description
It was reported that catheter entrapment on guidewire occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 4.00 x 32mm synergy drug-eluting stent was advanced for treatment.However, during the procedure, the stent became stuck with a non-boston scientific guidewire.The devices were removed as one unit and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: synergy xd mr ous 4.00 x 32mm was returned for analysis.Returned device analysis found that the distal extrusion (including the wire lumen) was stretched and bunched.As a result of this damage, it was not possible to pass a recommended 0.014 inch guidewire through the stretched and bunched lumen.Further analysis identified that the hypotube was kinked at various locations along its length.
 
Event Description
It was reported that catheter entrapment on guidewire occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 4.00 x 32mm synergy drug-eluting stent was advanced for treatment.However, during the procedure, the stent became stuck with a non-boston scientific guidewire.The devices were removed as one unit and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.
 
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Brand Name
SYNERGY XD
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
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16433241
MDR Text Key310138530
Report Number2124215-2023-05779
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeJA
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 04/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/16/2023
Device Lot Number0028492645
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2021
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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