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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 1013470-150
Device Problems Failure to Fold (1255); Inflation Problem (1310); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/24/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2019001. The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the mildly calcified superficial femoral artery with a flux occlusion. A 5. 5x150mm and two 5. 5x100mm supera self-expanding stents were implanted without any issues. A 6x150mm armada 18 percutaneous transluminal angioplasty (pta) balloon was advanced without resistance, but during the first inflation at 6 atmospheres (atms), the middle portion of the balloon did not fully inflate until the third inflation at the same pressure. The pta balloon was now fully inflated, and post-dilatation was complete. The balloon deflated, but the balloon did not refold tightly. During removal, the balloon felt resistance with the introducer sheath, and the pta catheter was removed with the non-abbott sheath as a single unit. A new sheath was advanced for confirmation imaging. There were no adverse patient effects and no clinically significant delay in the procedure. 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 (P099)
cashel road
clonmel tipperary
EI
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key9305061
MDR Text Key177209933
Report Number2024168-2019-13419
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 02/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1013470-150
Device Catalogue Number1013470-150
Device Lot Number9060741
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2019
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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