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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
Model Number 1013465-150
Device Problems Leak/Splash (1354); Product Quality Problem (1506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/21/2020
Event Type  malfunction  
Manufacturer Narrative
A visual and functional inspection was performed on the returned device. The reported irregular appearance of the refold was confirmed. Additionally, a leak in the sidearm was observed. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history of the reported lot revealed no other complaints. The investigation determined that the leak noted during functional testing of the returned unit appears to be related to a potential product quality issue. The issue is being addressed per internal operating procedures. Abbott vascular will continue to trend the performance of these devices.
 
Event Description
It was reported that the armada 18 was successfully inflated at 8 atmospheres in the posterior tibial artery and another distal artery without incident. The armada 18 was removed from the patient and the case continued. The physician was intending to use the armada 18 a third time in the patient when she noticed that the balloon did not appear to have re-wrapped correctly. It was decided to use an armada 35 to complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided. Analysis of the returned device identified a leak.
 
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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 (P099)
cashel road
clonmel tipperary
EI
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key9728251
MDR Text Key180131881
Report Number2024168-2020-01613
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
Report Date 02/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1013465-150
Device Catalogue Number1013465-150
Device Lot Number9092541
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/25/2019
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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