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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1008197-20
Device Problems Difficult to Remove ; Stretched; Improper or Incorrect Procedure or Method; Difficult to Advance
Event Date 09/11/2018
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 has not yet been received. 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 non-tortuous, mildly calcified iliac artery. A 6. 0x20mm viatrac balloon dilatation catheter failed to advance on a 0. 014 guide wire (gw) as it met resistance with the gw and got stuck. The device was removed and it was noted that the tip was damaged. No patient effects. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.

 
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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 Key8302281
Report Number2024168-2019-00802
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 03/14/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2019
Device Catalogue Number1008197-20
Device LOT Number8011661
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 Received02/28/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/01/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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