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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1014252-080
Device Problems Difficult to Flush ; Difficult to Remove ; Difficult to Advance
Event Date 05/28/2019
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 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. The ht command 18 guide wire referenced is being filed under a separate medwatch report.

 
Event Description

It was reported that the procedure was performed to treat a mildly tortuous and mildly calcified lesion in the superficial femoral artery (sfa), popliteal and peroneal arteries. The command 18 guide wire was advanced without reported issue. Next, a 5. 0x40mm armada 18 percutaneous transluminal angioplasty (pta) catheter was advanced without issue over the guide wire. The pta catheter was removed without reported issue, and a 2. 0x80mm armada otw pta catheter was then advanced without issue over the command 18 guide wire. While removing the guide wire to perform a guide wire exchange, slight resistance was noted between the devices. An unspecified. 014 guide wire was then attempted to be advanced; however, it would not advance through the pta catheter and was subsequently removed. The command 18 guide wire was then attempted to be reintroduced into the pta catheter when it was noted that the dark hydrophilic tip was missing. The pta catheter was unable to be aspirated. Angiography showed no visible wire in the vessels. The detached wire fragment was in the pta catheter which was removed in its entirety from the patient anatomy. Angiography confirmed no part of the guide wire remained in the vessel. An unspecified. 014 guide wire was then introduced into the patient, and the case was completed without further issue. After the procedure concluded, an attempt was made to flush the pta catheter outside of the patient anatomy, and the detached piece of the guide wire was pushed out from the catheter. There were no adverse patient effects, and there was no reported clinically significant delay in the procedure. No additional information was provided.

 
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Brand NameARMADA 18 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)
CLONMEL, IRELAND REG# 3005718570
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 Key8707844
Report Number2024168-2019-04784
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 07/17/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/18/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1014252-080
Device LOT Number8060741
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/25/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/2018
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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