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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 Problems Off-Label Use; Adverse Event Without Identified Device or Use Problem
Event Date 06/11/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). 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 the mid common carotid artery that did not have any tortuosity. A 190 cm emboshield nav6 embolic protection device (epd) was positioned, and pre-dilatation was performed with a 3. 0 x 20 mm nc trek balloon catheter. A non-abbott stent was then implanted, and post-dilatation was performed with a 5. 0 x 20 mm viatrac balloon catheter. A neurological test was done, and it was noted that the stent was occluded with thrombus or soft plaque, and there was an issue with the non-abbott stent reducing flow. The epd had captured embolis and was blocked. Therefore, the epd was aspirated and removed. The non-abbott stent was still reducing flow. A 30 x 9-7 mm xact stent was then implanted inside the non-abbott stent for support, and standard post-dilatation was performed with a 4. 0 x 20 mm viatrac balloon catheter. Another neurological test was done and the occlusion was still noted. It was not possible to aspirate as the occlusion was too distal; therefore, the patient was sent to the intensive care unit (icu) and anticoagulation was performed. 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 Key8761357
Report Number2024168-2019-05411
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 08/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/03/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1008193-20
Device LOT Number9030661
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 Received07/17/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/03/2019 Patient Sequence Number: 1
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