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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 0031209042
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/08/2023
Event Type  malfunction  
Event Description
It was reported that foreign material was present on the device.A 3.00 x 32mm synergy xd drug -eluting stent was selected for use.However, when the package was opened and inspected, grit on the catheter was noted.The procedure was completed using an alternate device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: a synergy xd mr us 3.00 x 32mm was returned for analysis.A visual, tactile and microscopic examination along with a dimensional test was performed.Device analysis could not identify any foreign material attached to the device consistent with the reported "grit".Although blood was visible on the hub/manifold, it is likely that this occurred during the initial handling of the device, during the intended procedure.Further analysis identified that some stent struts were lifted around the mid-body of the balloon and it was identified that the distal tip end of the device was compressed.The reported event of foreign material was not confirmed.
 
Event Description
It was reported that foreign material was present on the device.A 3.00 x 32mm synergy xd drug -eluting stent was selected for use.However, when the package was opened and inspected, grit on the catheter was noted.The procedure was completed using an alternate device.No patient complications were reported.
 
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Brand Name
SYNERGY XD
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 Key17644077
MDR Text Key322203191
Report Number2124215-2023-44205
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729981008
UDI-Public08714729981008
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0031209042
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received10/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/06/2023
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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