• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT VASCULAR ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1014261-120
Device Problems Inflation Problem (1310); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/12/2019
Event Type  Malfunction  
Manufacturer Narrative

Exemption number e2019001. It is unknown if the device is returning for analysis. A follow up report will be submitted with all additional relevant information. The additional armada device referenced is being filed under separate medwatch report number.

 
Event Description

It was reported that the patient presented with occlusion of the lower leg arteries, a non-healing wound of the left lower leg and foot and ischemia. The procedure was to treat the left tibial and anterior tibial arteries and recanalization of the anterior tibial artery was performed. A non-abbott balloon dilatation catheter (bdc) was used to dilate first and then an armada 18 3. 0x120 mm percutaneous transluminal angioplasty (pta) catheter was attempted for dilatation. It was noted that the catheter did not fill with contrast and the liquid was dripping from the junction of the catheter and the connector. There were no signs of balloon inflation on angiography. Another, same size armada 18 pta catheter was then attempted, but failed for the same reason. When trying to create a vacuum, bubbles began to flow into the syringe and when trying to pump contrast, it flowed out in drops at the point of attachment of the balloon delivery system. An armada 18 3. 0x200 mm was then used successfully to complete the procedure. There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure. No additional information was provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9413552
MDR Text Key177766934
Report Number2024168-2019-14142
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeRS
PMA/PMN NumberK151317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/12/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2019
Device Catalogue Number1014261-120
Device LOT Number6072741
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 Received02/11/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/27/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-