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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT TREK-VASCULAR BALLOON CATHETER CORONARY DILATATION

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ABBOTT VASCULAR ABBOTT TREK-VASCULAR BALLOON CATHETER CORONARY DILATATION Back to Search Results
Model Number 1012455-1-2
Device Problems Break (1069); Device Dislodged or Dislocated (2923)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/07/2016
Event Type  Injury  
Event Description
Balloon catheter broke in left main artery. All was removed from pt but the sheath needed to be removed immediately to dislodge the broken catheter and balloon.
 
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Brand NameABBOTT TREK-VASCULAR
Type of DeviceBALLOON CATHETER CORONARY DILATATION
Manufacturer (Section D)
ABBOTT VASCULAR
santa clara CA 95054
MDR Report Key6185822
MDR Text Key62825899
Report NumberMW5066772
Device Sequence Number1
Product Code LOX
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/13/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1012455-1-2
Device Lot Number50914G1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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