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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 B2060-250
Device Problems Difficult to Remove ; Material Rupture; Stretched
Event Date 06/21/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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 to treat a totally occluded de novo lesion located in the right superficial femoral artery. The armada was advanced to the lesion, and when inflated, the balloon ruptured during the first inflation at nominal pressure due to the calcified anatomy. When the delivery system was withdrawn, there was resistance and the balloon came out stretching on the guide wire. A glide catheter was used over the 014 wire to successfully retrieve the balloon. The case was aborted. The patient will be brought back at a later date to complete the procedure. There was no reported adverse patient effect or a 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 Key8795683
Report Number2024168-2019-10095
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/07/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberB2060-250
Device LOT Number90305G1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/02/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/05/2019
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: 07/16/2019 Patient Sequence Number: 1
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