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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT VASCULAR ARMADA 35 10.0MM X 20MM X 135CM OTW PTA ARMADA PTA CATHETER

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ABBOTT VASCULAR ABBOTT VASCULAR ARMADA 35 10.0MM X 20MM X 135CM OTW PTA ARMADA PTA CATHETER Back to Search Results
Catalog Number B2100-020
Device Problems Difficult to Remove (1528); Material Rupture (1546); Device Or Device Fragments Location Unknown (2590)
Patient Problem No Information (3190)
Event Date 05/21/2018
Event Type  Injury  
Event Description
During angioplasty within existing fractured stents the balloon ruptured and due to difficulty removing, it was removed along with the wire and the sheath as a unit. The balloon tip was unaccounted for.
 
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Brand NameABBOTT VASCULAR ARMADA 35 10.0MM X 20MM X 135CM OTW PTA
Type of DeviceARMADA PTA CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
MDR Report Key7641154
MDR Text Key112583781
Report NumberMW5078087
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 Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Catalogue NumberB2100-020
Device Lot Number70714G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 06/26/2018 Patient Sequence Number: 1
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