• 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 B1060-100
Device Problems Off-Label Use; Difficult to Remove ; Difficult to Advance
Event Date 01/29/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). Concomitant medical products: guide wire: 0. 032 inch 180 cm/ medikit. Sheath: mosquito sincere catheter introducer 5f 4 cm. The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.

 
Event Description

It was reported that the procedure was to treat an unspecified mildly tortuous, concentric and mildly calcified artery in the upper arm that had a shunt placed, which was restenosed. A 6. 0 x 100 mm armada 35 balloon catheter was used for pre-dilatation two times; however, the device became stuck with a non-abbott guide wire. Therefore, both devices were removed as a single unit. There was a failed attempt to advance the armada 35 balloon catheter again as it met resistance with an unspecified guide wire. The device was then not able to be inserted inside the introducer sheath. Therefore, an unspecified balloon catheter was used to successfully complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. 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 Key8362441
Report Number2024168-2019-01347
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/20/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/22/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberB1060-100
Device LOT Number80512G1
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer02/20/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2019
Was Device Evaluated By Manufacturer? Yes
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

-
-