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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 B1060-040
Device Problems Material Rupture (1546); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/23/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was discarded and 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. Based on the information provided, the balloon rupture appears to be due to case circumstances. It is likely that the resistance during advancement and balloon were due to interaction with the calcified lesion causing damage to the outer surface of the balloon material. 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 on 03/23/2020, a percutaneous intervention was performed on a moderately calcified lesion within an arteriovenous fistula (avf). The armada dilatation catheter advanced to the lesion with resistance. The device reached the lesion site and balloon dilatation was performed two times. The balloon burst at 20 atmospheres. There were no adverse patient effects and there was no clinically significant delay. No additional information was provided regarding this issue.

 
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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 Key9960314
MDR Text Key187703314
Report Number2024168-2020-03658
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeTW
PMA/PMN NumberK111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 04/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/14/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberB1060-040
Device Catalogue NumberB1060-040
Device LOT Number90925G1
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 Received03/24/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/25/2019
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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