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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER

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ABBOTT VASCULAR ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number UNK ARMADA 35
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Aneurysm (1708); Arrhythmia (1721); Stroke/CVA (1770); Hematoma (1884); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Renal Failure (2041); Perforation of Vessels (2135); Obstruction/Occlusion (2422); Pseudoaneurysm (2605); Vascular Dissection (3160); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)
Event Date 04/09/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: estimated date. The udi number is "ni" as the part number was not provided. The device is not returning for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The additional patient effects, malfunctions, and devices referenced in the report are captured under separate medwatch report numbers. Literature attachment titled ¿post market clinical follow-up evaluation report peripheral dilatation catheter family¿.
 
Event Description
The post-market clinical follow-up (pmcf) report, titled ¿post market clinical follow-up evaluation report peripheral dilatation catheter family¿ evaluated the safety and performance of the viatrac 14 plus, armada 14, armada 14xt, armada 18, armada 35, and the armada 35 ll. It was reported through a pmcf report that the armada 35 may be related to unsuccessful dilatation of a vessel, stent, and/or chronic total occlusion, unsuccessful delivery, inflation, and/or deflation, twisting of the balloon when used twice, embolism, dissection, perforation, limb amputation, total occlusion, abrupt closure, arrhythmia, renal failure, stroke, thrombosis, occlusion, venous hypertension, aneurysm, pseudoaneurysm, hematoma, and hemorrhagic events. Although the above events were noted, in conclusion, the overall analyses from this study demonstrates that the use of the abbott dilatation catheters met the safety and performance criteria and perform similarly to competitive state of the art devices.
 
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Brand NameARMADA 35 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key12741103
MDR Text Key279826669
Report Number2024168-2021-09894
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK ARMADA 35
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/16/2021
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

Patient Treatment Data
Date Received: 11/02/2021 Patient Sequence Number: 1
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