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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER

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ABBOTT VASCULAR ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1013466-100
Device Problem Component Misassembled (4004)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/22/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2019001. Visual and dimensional analysis was performed on the returned device. The reported undersized balloon was not 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 indication of a lot specific product issue. The investigation determined that the device met specification. The distance between the markers on the returned product was within specification and there is no indication of a product quality issue with respect to manufacture, design, or labeling.
 
Manufacturer Narrative
The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. Exemption number e2019001.
 
Event Description
It was reported that the 4. 0x100 armada 18 balloon dilatation catheter was inserted to post dilate the 6. 0x100 absolute pro vascular stent in the superficial femoral artery. When the armada was inflated to nominal pressure, it appeared to be the correct 100 mm length; however, the balloon markers did not line up with the shoulders of the balloon. The markers appeared shorter than the 100 mm length. The stent was successfully postdilated and there were no adverse patient effects. There was no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameARMADA 18 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 Key9305536
MDR Text Key170358907
Report Number2024168-2019-13428
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151317
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 12/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2019
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1013466-100
Device Lot Number9060541
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/05/2019
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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