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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER

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ABBOTT VASCULAR ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number A2025-120
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 02/06/2020
Event Type  Malfunction  
Manufacturer Narrative

The device has been received. A follow-up report will be submitted with all additional relevant information.

 
Event Description

It was reported that the box for an armada 14 was pulled and just before use, the device was noted to be an armada 35 percutaneous transluminal angioplasty (pta) catheter. The discrepancy was noted before use and the device was not used. A new device was pulled and was able to be successfully used. Reportedly, the account may have inadvertently placed the wrong device in the box but that could not be confirmed. There was no clinically significant delay in the procedure. No additional information was provided.

 
Manufacturer Narrative

The device was returned for analysis. The reported product discrepancy was confirmed. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents reported from this lot. There is no indication of a product quality issue with respect to manufacture, design or labeling. The investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that a mix-up occurred at the hospital. There is no indication of a product quality issue with respect to manufacture, design or labeling.

 
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Brand NameARMADA 14 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005718570 (P099)
cashel road
clonmel tipperary
EI
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key9766136
MDR Text Key181342285
Report Number2024168-2020-01857
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK102705
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 04/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/27/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberA2025-120
Device Catalogue NumberA2025-120
Device LOT Number9061741
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/26/2020
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? Yes
Date Device Manufactured06/17/2019
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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