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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY MONORAIL CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY MONORAIL CORONARY STENT SYSTEM; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 08714729840299
Device Problems Fracture (1260); Difficult to Remove (1528)
Patient Problem Death (1802)
Event Date 12/21/2019
Event Type  Death  
Event Description
During cardiac catheterization stent balloon unable to be removed from the lcx after stent deployed.Multiple techniques used to try to dislodge it.Shaft of catheter broke from balloon.Pt retains foreign body following procedure.Needed to have open heart surgery to try and prevent further injury.Examination of the fractured balloon which was still in the possession of the cath lab staff revealed that the balloon fractured at the wire exit site from the monorail catheters.Fda safety report id# (b)(4).
 
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Brand Name
SYNERGY MONORAIL CORONARY STENT SYSTEM
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
marlborough MA 01752
MDR Report Key9538620
MDR Text Key173450219
Report NumberMW5091948
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/06/2020
Device Model Number08714729840299
Device Catalogue NumberH7493926028300
Device Lot Number22236415
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age75 YR
Patient Weight94
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