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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
Model Number H7493941832300
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/12/2020
Event Type  malfunction  
Event Description
It was reported that a labeling issue occurred.During preparation and while outside the patient, a box labelled as a 3 x32 synergy xd stent had a 3x20 synergy xd stent enclosed.It was noted that there was not an attempt to implant the 3x20 synergy xd stent device.The procedure was completed successfully and no patient complications resulted in relation to this event.
 
Event Description
It was reported that a labeling issue occurred.During preparation and while outside the patient, a box labelled as a 3 x32 synergy xd stent had a 3x20 synergy xd stent enclosed.It was noted that there was not an attempt to implant the 3x20 synergy xd stent device.The procedure was completed successfully and no patient complications resulted in relation to this event.
 
Manufacturer Narrative
Device evaluated by mfr: the outer carton packaging of 3.00 x32mm synergy xd was returned for analysis.Inside was a sealed foil pouch and patient information guide leaflet (lot 25638463 upn h7493941832300 ,exp 22.06.2022) with blue tab not intact.All labels are legible, slight crease on edge of the box.Sealed foil pouch within shelf carton ( lot 25588953, upn h7493941820300 exp 27-05-2022).All label is legible.The seal foil pouch was opened by analyst to document device details: unused device in hoop was a synergy xd 3.00/20 lot 25569516-009.No other issues noted.
 
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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
MDR Report Key10780304
MDR Text Key214528539
Report Number2134265-2020-15172
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729981008
UDI-Public08714729981008
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/09/2020
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 Expiration Date06/22/2022
Device Model NumberH7493941832300
Device Lot Number0025638463
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/28/2020
Initial Date Manufacturer Received 10/12/2020
Initial Date FDA Received11/03/2020
Supplement Dates Manufacturer Received11/25/2020
Supplement Dates FDA Received12/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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