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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER SELECT; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER SELECT; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10662
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2023
Event Type  malfunction  
Manufacturer Narrative
Used the first date of the month of the aware date as no event date was provided.
 
Event Description
It was reported that device was not sterile.During preparation, it was noted that a 12 x 3.00 promus premier select drug-eluting stent had come in contact with an infectious disease.There were no patient complications reported.
 
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Brand Name
PROMUS PREMIER SELECT
Type of Device
STENT, CORONARY, DRUG-ELUTING
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 Key16565310
MDR Text Key311502709
Report Number2124215-2023-12486
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10662
Device Catalogue Number10662
Device Lot Number0029612413
Was Device Available for Evaluation? No
Date Manufacturer Received02/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/08/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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