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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 B2060-040
Device Problems Off-Label Use (1494); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/20/2021
Event Type  Injury  
Manufacturer Narrative
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 patient came in due to a stroke and the procedure was to treat a mildly calcified vessel in the left carotid artery. Pre-dilatation was performed with a 4. 0x40mm armada balloon without issue. Thrombectomy was performed. The 6. 0x40mm armada percutaneous transluminal angioplasty (pta) catheter was prepared (air aspiration) outside the anatomy prior to use without any issues. There was no resistance during advancement through a telescoping catheter. However, the armada was inflated once to nominal pressure and the balloon ruptured. It was noted that when removing the balloon, there was resistance noted as the balloon would not pull back into the catheter. The balloon and catheter were then proceeded to be pulled out together. The patient had prior stents in the iliacs. There was resistance felt as the balloon was being pulled out through the iliacs and the tip separated. The tip was left in the patient free floating in the aorta around the level of the renal artery. There was 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 Key13192123
MDR Text Key283406386
Report Number2024168-2022-00234
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2060-040
Device Catalogue NumberB2060-040
Device Lot Number90917G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2019
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: 01/07/2022 Patient Sequence Number: 1
Treatment
TELESCOPING CATHETER
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