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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 B1050-040
Device Problems Difficult to Remove (1528); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/25/2020
Event Type  Malfunction  
Manufacturer Narrative

The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.

 
Event Description

It was reported that the procedure was to treat a 90% stenosed lesion with no significant calcification or tortuosity in the distal superficial femoral artery. A 5x40x80 armada catheter was inserted; however, the guide wire jammed in the catheter shaft during advancement. The device was removed as a single unit. The procedure was successfully completed with a new guide wire and a new balloon catheter. There was no clinically significant delay in the procedure and no adverse patient sequela. 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 Key9962422
MDR Text Key187729760
Report Number2024168-2020-03667
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberB1050-040
Device Catalogue NumberB1050-040
Device LOT Number90913G1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/16/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/13/2019
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: 04/15/2020 Patient Sequence Number: 1
Treatment
.035 GUIDE WIRE
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