• 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 RX VIATRAC 14 PLUS 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 RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1008189-30
Device Problem Device Markings / Labelling Problem
Event Date 10/10/2018
Event Type  Malfunction  
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. A review of the lot history record identified one similar incident associated with this complaint. The investigation determined the labeling issue appears to be related to a potential product quality issue. The issue is being addressed per internal operating procedures. Abbott vascular will continue to trend the performance of these devices.

 
Event Description

It was reported that the part number on the international label (chinese) of a 4x30mm rx viatrac plus peripheral dilatation catheter did not match the part number on the english label on the box. The dilation catheter was not used. There was no patient involvement. No additional information was provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
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 Key8011639
Report Number2024168-2018-08223
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/28/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1008189-30
Device LOT Number8081061
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-