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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 H7493941848270
Device Problems Device Markings/Labelling Problem (2911); Wrong Label (4073)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2022
Event Type  malfunction  
Event Description
It was reported that improper labeling occurred.A 2.75mm x 48mm synergy xd drug eluting stent was selected for use.However, it was noted that the size of the stent within the box was incorrect.The box was labeled for 2.75mm x 48mm synergy xd; however, the hub of the device was labelled 2.75mm x 38mm.The procedure was completed with another of the same device.There were no complications reported.
 
Event Description
It was reported that improper labeling occurred.A 2.75mm x 48mm synergy xd drug eluting stent was selected for use.However, it was noted that the size of the stent within the box was incorrect.The box was labeled for 2.75mm x 48mm synergy xd; however, the hub of the device was labelled 2.75mm x 38mm.The procedure was completed with another of the same device.There were no complications reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: a synergy xd monorail 2.75 x48, lot #28500494 was returned with the outer clear seal opened.No issues noted with packaging carton (opened).Foil pouch opened inside carton and there was no patient information guide inside carton.Device inside the packaging was a synergy xd 2.75/38, lot # 27796598-075.Incorrect device inside carton.
 
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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
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15588925
MDR Text Key301587976
Report Number2124215-2022-41014
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729985211
UDI-Public08714729985211
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 Physician
Type of Report Initial,Followup
Report Date 12/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/22/2023
Device Model NumberH7493941848270
Device Lot Number0028500494
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/22/2021
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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