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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 H7493952824300
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 04/28/2014
Event Type  malfunction  
Event Description
It was reported that foreign matter was identified.A 3.00x24mm promus premier¿ drug eluting stent was selected.While unpacking the device, it was noted that there was a hair on the hoop.The procedure was completed with another of the same device.No patient complications were reported and the patient¿s status was fine.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Device evaluated by mfr: returned for analysis was an opened pouch with the device inserted through the carrier tube.A hair was inside the pouch.The hair measured approximately 140mm in length.The hair had a bulbous appearance at one end, which is consistent with that of a hair follicle.As the packaging had been opened on returned of the device it is not possible to determine the origin of the hair returned with the device.No other issues were noted with the returned device or packaging.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).
 
Event Description
It was reported that foreign matter was identified.A 3.00x24mm promus premier¿ drug eluting stent was selected.While unpacking the device, it was noted that there was a hair on the hoop.The procedure was completed with another of the same device.No patient complications were reported and the patient¿s status was fine.
 
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Brand Name
PROMUS PREMIER?
Type of Device
STENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
ingrid matte
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key3835337
MDR Text Key4499834
Report Number2134265-2014-02855
Device Sequence Number1
Product Code NIQ
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 Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 04/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/04/2014
Device Model NumberH7493952824300
Device Catalogue Number39528-2430
Device Lot Number16635012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/30/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2014
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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