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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 B2100-040
Device Problems Off-Label Use; Material Rupture; Material Separation
Event Date 12/30/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history of the reported lot revealed no other complaints. The armada 35 is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula. This device is also indicated for stent post-dilatation in the peripheral vasculature. Based on the information provided, the reported balloon rupture, material separation and additional treatment to snare the separated material appear to be due to circumstances of the procedure. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

 
Event Description

It was reported that after advancing an armada balloon dilatation catheter to the heavily scarred abdominal aorta near where an inferior vena cava (ivc) filter and previously placed stents were located, the balloon ruptured during the first inflation, below the rated burst pressure and the distal shaft separated. The separated shaft was successfully snared and removed. There was no adverse patient sequela or a clinically significant delay in 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 Key9623690
Report Number2024168-2020-00866
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberB2100-040
Device Catalogue NumberB2100-040
Device LOT Number90701G1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/31/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2019
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: 01/23/2020 Patient Sequence Number: 1
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