• 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 35 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 35 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number B1060-080
Device Problems Difficult to Remove (1528); Material Rupture (1546); Stretched (1601)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/10/2021
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned for evaluation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported this was a procedure to treat heavily calcified ne novo lesion of the left popliteal artery. An armada 35 6x80 mm was inserted and inflated to 12atm. The device functioned as intended, so the physician moved the balloon proximal and inflated again with 12atm. However, this time, the balloon burst. The physician then attempted to pull the balloon into the 6f catheter but was unable to do so. Angiography showed the balloon had become stretched and had curled up. The physician then pulled all the devices back towards the puncture site. While removing the devices out of the patient through the common femoral artery, the balloon became stuck on the catheter and also became stuck in the puncture site. For removal, a surgeon had to surgically open the common femoral artery resulting in a clinically significant delay in the procedure. The device was successfully removed, and no additional treatment was performed. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12647653
MDR Text Key276882656
Report Number2024168-2021-09301
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB1060-080
Device Catalogue NumberB1060-080
Device Lot Number10311G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/18/2021 Patient Sequence Number: 1
Treatment
GUIDE CATHETER
-
-