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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT ABBOTT ARMADA 14 PTA CATHETER 4.0 MM X 120 MM X 150

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ABBOTT ABBOTT ARMADA 14 PTA CATHETER 4.0 MM X 120 MM X 150 Back to Search Results
Model Number A2040-120
Device Problems Retraction Problem (1536); Wire(s), breakage of (2347); Device Issue (2379)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 05/16/2018
Event Type  Injury  
Event Description
Patient had an ultrasound guided access left lower extremity popliteal vein balloon angioplasty. A retained 014 balloon tip and retained wire noted in left femoral vein; this occurred due to inability to remove balloon with deflation and other deflating maneuvers; wire sheared at popliteal access most likely due to multiple attempts to advance sheath over the wire to attempt new access and remove/snare 014 wire.
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Brand NameABBOTT
Type of DeviceARMADA 14 PTA CATHETER 4.0 MM X 120 MM X 150
Manufacturer (Section D)
abbott park IL
MDR Report Key7615113
MDR Text Key111814845
Report Number7615113
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/06/2018,05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Model NumberA2040-120
Device Catalogue NumberA2040-120
Device Lot Number7121241
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/14/2018
Distributor Facility Aware Date05/16/2018
Device Age5 MO
Event Location Hospital
Date Report to Manufacturer06/14/2018
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/14/2018 Patient Sequence Number: 1