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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING

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BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9584
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 09/16/2018
Event Type  malfunction  
Event Description
It was reported that mislabeling occurred.During unpacking of an promus premier stent, it was noticed that the size on the package (3.5mmx16mm) and the device inside (3.5mmx20mm) did not match.The device was not used and a new promus premier stent was used to complete the procedure.No patient complications were reported.
 
Event Description
It was reported that mislabeling occurred.During unpacking of an promus premier stent, it was noticed that the size on the package (3.5mmx16mm) and the device inside (3.5mmx20mm) did not match.The device was not used and a new promus premier stent was used to complete the procedure.No patient complications were reported.The device was returned in an opened outer box.The blue tab seal was not intact.The outer box packaging was labelled as promus premier 3.50 x 16 mm batch# 22290101.A foil pouch with seal intact labelled promus premier 3.50 x 20 mm batch# 21942673 was inside the opened box packaging labelled promus premier 3.50 x 16 mm batch# 22290101.The foil pouch opened by analyst and the inner tyvek pouch labelled promus premier 3.50 x 20 mm batch# 21942673 was inside with seal intact lot# 21932653-019.No other issues were identified during product analysis.Analysis determined that the condition of the returned device was consistent with the complaint incident as the label on the outer box packaging was different from the label on the actual device inside the box.The outer box packaging was returned open with the blue tab seal broken.A general action was assigned to the secondary pack product unit for manufacturing information and a response was received which confirmed that controls are in place during the manufacturing process to prevent incorrect labelling and that the two batches were manufactured and packaged on different dates.This is not a manufacturing issue, the incident cannot be confirmed.
 
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Brand Name
PROMUS PREMIER
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key7957814
MDR Text Key123490971
Report Number2134265-2018-61713
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729844747
UDI-Public08714729844747
Combination Product (y/n)N
PMA/PMN Number
P110010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/06/2018
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 Date12/10/2019
Device Model Number9584
Device Catalogue Number9584
Device Lot Number0022290101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/23/2018
Initial Date Manufacturer Received 09/17/2018
Initial Date FDA Received10/11/2018
Supplement Dates Manufacturer Received11/15/2018
Supplement Dates FDA Received12/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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