• 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 B1070-040
Device Problems Product Quality Problem (1506); Difficult to Remove (1528); Material Rupture (1546); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/08/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. The customer reported the device was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion located in the iliac artery. The armada balloon was advanced into the 6f introducer, but when the physician wanted to remove it, force was applied, and the balloon catheter was damaged. The introducer and the balloon were removed together. There was no reported adverse patient effect or a clinically significant delay. 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
lindsey bell
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key8606190
MDR Text Key144951355
Report Number2024168-2019-03783
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 09/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2021
Device Catalogue NumberB1070-040
Device Lot Number80505G1
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 Received08/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-