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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE OMEGA¿; STENT, CORONARY
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BOSTON SCIENTIFIC - MAPLE GROVE OMEGA¿; STENT, CORONARY Back to Search Results
Model Number H7493913824450
Device Problem Premature Activation (1484)
Patient Problem No Patient Involvement (2645)
Event Date 10/26/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the stent deployed prematurely.During unpacking of a 24x4.50 omega stent from its sterile pack, it was noted that the edges of the stent were already expanded by the balloon.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an omega sds with stent.There was contrast in the inflation lumen and blood in the hub.Although it was reported that the device was not used, the presence of blood in the hub and contrast media in the inflation lumen is indicative of handling beyond simply unpacking the device, as was reported.The distal tip was damaged.Microscopic examination revealed that the stent was secure on the balloon between the markerbands.There was no damage or irregularities to the stent.The ends of the stent were partially deployed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
Event Description
It was reported that the stent deployed prematurely.During unpacking of a 24x4.50 omega stent from its sterile pack, it was noted that the edges of the stent were already expanded by the balloon.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
 
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Brand Name
OMEGA¿
Type of Device
STENT, CORONARY
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5230339
MDR Text Key31401239
Report Number2134265-2015-07888
Device Sequence Number1
Product Code MAF
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/05/2016
Device Model NumberH7493913824450
Device Catalogue Number39138-2445
Device Lot Number15926876
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/10/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/08/2013
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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