• 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 14 XT 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 14 XT PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number F2015-020
Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/06/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was not returned for evaluation. 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 and/or complaints from this lot. It was reported that the device was prepped inside the anatomy. It should be noted that the percutaneous transluminal angioplasty (pta), armada 14 xt, over the wire (ot), global instructions for use (ifu) specifies: caution: all air must be removed from the balloon and displaced with contrast medium (diluted 1:1 with normal saline) prior to inserting into the body (repeat steps 4a through 4g, if necessary); otherwise, complications may occur. In this case, it is unknown if the ifu violation caused or contributed to the reported complaint. The investigation determined the reported complaints appear to be related to operational context. 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 the procedure was to treat a 100% stenosed, heavily calcified, mildly tortuous, chronic totally occluded (cto) lesion in the superficial femoral artery (sfa). The 1. 5x20 mm armada 14 percutaneous transluminal angioplasty (pta) catheter was not air aspirated outside the anatomy prior to use in the patient. The device was advanced with resistance noted with the anatomy and was inflated twice to 8 atmospheres (atm). The balloon ruptured and would not inflate a third time. A 1. 5x40 mm armada 14 pta catheter was used in replacement. There were no adverse patient effects and there was no clinically significant delay in the procedure. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARMADA 14 XT 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 Key12344440
MDR Text Key267341843
Report Number2024168-2021-07315
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K121352
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberF2015-020
Device Catalogue NumberF2015-020
Device Lot Number00713G1
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 Received08/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-