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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿; STENT, CORONARY, DRUG-ELUTING
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BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿; STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number H7493952838300
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/07/2017
Event Type  malfunction  
Manufacturer Narrative
Device is a combination product.(b)(4).
 
Event Description
It was reported that a foreign matter was found.The target lesion was located in a coronary artery.A 3.00x38mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.After several attempts, it was noted that there was a chuck of plastic obstructing the hub.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the stent delivery system (sds) was returned for analysis.A visual examination of the stent found no issues on the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal markerbands.The crimped stent od (outer diameter) was measured and the result was within maximum crimped stent profile measurement.The bumper tip profile of the device showed no signs of damage.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination found no issues with the hypotube profile.The manifold hub of the device was visually examined and no issues were noted with external section of manifold hub and the threads showed no signs of damage.The internal surface of the leur section of the manifold hub appeared to be crushed with a rough edge in one section.The manifold hub was attached to a hand held encore inflation device with no issue noted with the threading.A visual and tactile examination of the outer and mid-shaft section found no issues with the extrusion profile.The bi-component bond showed no signs of damage or strain.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
 
Event Description
It was reported that a foreign matter was found.The target lesion was located in a coronary artery.A 3.00x38mm promus premier¿ drug-eluting stent was advanced but failed to cross the lesion.After several attempts, it was noted that there was a chuck of plastic obstructing the hub.No patient complications were reported.
 
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Brand Name
PROMUS PREMIER¿
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6377190
MDR Text Key69105799
Report Number2134265-2017-01913
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729845027
UDI-Public(01)08714729845027(17)20180508(10)19967459
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/08/2018
Device Model NumberH7493952838300
Device Catalogue Number39528-3830
Device Lot Number19967459
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received04/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2016
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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