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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
Model Number B1070-080
Device Problem Difficult to Remove (1528)
Patient Problem Aneurysm (1708)
Event Date 01/15/2021
Event Type  Injury  
Manufacturer Narrative
The device will not be returned for evaluation as the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that this was a procedure to treat thrombosis in the left arteriovenous (av) fistula. An armada balloon catheter was inserted, and angioplasty was performed. However, after angioplasty was performed, angiogram showed residual thrombus and an aneurysm of the av fistula. A high-grade stenosis of the av fistula was also noted. During removal of the balloon catheter, the physician stated that due to patient anatomy, the device was difficult to remove. The balloon catheter was able to be removed without causing damage to the patient. To further treat the stenosed area, a non-abbott device was successfully used. 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 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 Key11308107
MDR Text Key231169798
Report Number2024168-2021-01061
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB1070-080
Device Catalogue NumberB1070-080
Device Lot Number01016G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2020
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: 02/10/2021 Patient Sequence Number: 1
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