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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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ABBOTT VASCULAR ARMADA 35 PTA CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number B2140-040
Device Problem Structural Problem (2506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/02/2019
Event Type  malfunction  
Event Description
Balloon was prepped and used to pre dilate an aortic valve. The balloon did not rupture. When balloon was removed a small plastic piece was hanging. The doctor is not sure if it happened during removal from the sheath/body.
 
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Brand NameARMADA 35 PTA CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591
MDR Report Key9362456
MDR Text Key167597576
Report Number9362456
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2140-040
Device Catalogue NumberB2140-040
Device Lot Number90819G1
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/30/2019
Event Location Hospital
Date Report to Manufacturer11/22/2019
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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