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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 1008193-20
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 03/13/2019
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 device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that before use, it was noted that the tyvek pouch containing a 5. 0 x 20 mm viatrac plus balloon catheter was not sealed and had a tear in the middle. Therefore, the balloon catheter was replaced with an unspecified device to successfully complete the procedure. There was no patient involvement. 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
lindsey bell
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key8486859
MDR Text Key141037240
Report Number2024168-2019-02684
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102705
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,Followup
Report Date 09/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Catalogue Number1008193-20
Device Lot Number9021361
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 Received08/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2019
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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