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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 B1120-060
Device Problems Off-Label Use (1494); Material Rupture (1546)
Patient Problem Insufficient Information (4580)
Event Date 03/05/2021
Event Type  malfunction  
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. Na.
 
Event Description
It was reported that the procedure was performed to treat a lesion with 55% stenosis in the right external iliac vein. A 12 x 60mm armada 35 balloon dilatation catheter (bdc) was advanced to the target lesion for off-label use; however, the balloon ruptured after first inflation at 4 atmospheres. The armada 35 bdc with the ruptured balloon was simply removed from the anatomy. The procedure ended at this point. There were no reported adverse patient effects and no reported 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 Key11562206
MDR Text Key243616717
Report Number2024168-2021-02328
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
Report Date 04/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB1120-060
Device Catalogue NumberB1120-060
Device Lot Number90918G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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