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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER

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ABBOTT VASCULAR ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1013456-200
Device Problem Component Misassembled (4004)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2019
Event Type  malfunction  
Event Description
It was reported that the procedure was to treat a moderately calcified lesion in the superficial femoral artery (sfa). The 4. 0x200mm armada 18 balloon catheter was advanced to the target lesion and inflated to nominal pressure when it was noted the proximal balloon marker was located inside the balloon working length, not on the shoulder where it should be. Although the balloon markers were slightly off, the balloon worked as intended. The same balloon was used to successfully complete the procedure. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.
 
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Brand NameARMADA 18 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG #3005718570
cashel road
clonmel tipperary
EI
Manufacturer Contact
connie speck
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key8782333
MDR Text Key150852779
Report Number2024168-2019-10039
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1013456-200
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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