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

MAUDE Adverse Event Report: AV-TEMECULA-CT 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
 

AV-TEMECULA-CT ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number B2100-060
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/07/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was not returned for analysis. It may be possible that the balloon became entrapped within the vessel causing the separation during removal; however, this could not be confirmed. Without having the device to examine, the investigation was unable to determine a conclusive cause for the reported difficulties. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history of the reported lot revealed no other incidents. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
The following information is from a user facility medwatch report: per rn description: armada 35 pta catheter detached within patient. The balloon was inflated then deflated and when dr. Was moving the device out it snapped apart leaving half of the balloon inside the patient. The balloon was able to be removed. Per md: the patient did have an occlusion of the innominate vein with small collaterals filling that region. The decision was made to intervene. We upsized the sheath to a 7-french sheath and crossed the lesion with a berenstein catheter as well as a glidewire. After this was crossed, we then used a 6 x 200 mm armada balloon to balloon the entire region. We then used an 8 x 80 armada balloon without good success and we upsized to a 10 x 60 armada balloon. The armada balloon was taken down, and while withdrawing the armada balloon, the proximal portion of the balloon became disrupted and was only partially removed. The remaining distal portion was still on the wire. We then upsized the sheath to a 10-french sheath and used buddy wire technique to snare the rosen wire and removed the entire apparatus. We then placed pressure over the wound, used 4-0 monocryl to close the subcuticular layer over this and we applied venous pressure for greater than 15 minutes. This was then hemostatic. The balloon was evaluated and all the balloon was removed after the snare technique. 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)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
EL COYOL, COSTA RICA REG# 3009031392
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key6589803
MDR Text Key75916319
Report Number2024168-2017-04465
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 05/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Catalogue NumberB2100-060
Device Lot Number60830G1
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 Received05/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2016
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: 05/24/2017 Patient Sequence Number: 1
-
-