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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 1014255-150
Device Problems Off-Label Use; Material Rupture
Event Date 02/07/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). The device was not returned for analysis. It should be noted that the instructions for use, states: the armada 18 is indicated to dilate stenosis in femoral, popliteal, infra-popliteal, tibial, peroneal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In this case, it could not be determined if using the armada 18 in the brachial artery contributed to the rupture. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history of the reported lot revealed no other incidents. The investigation determined that the reported balloon rupture appears to be related to circumstances of the procedure. It is likely that the rupture occurred due to interaction with the lesion site which was described as narrow, heavily calcified and 80% stenosed. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

 
Event Description

It was reported that the procedure was performed to treat a narrow, heavily calcified, 80% stenosed de novo lesion in the mid brachial artery. After being prepped without any issues, a 4. 0x150mm armada 18 percutaneous transluminal angioplasty (pta) balloon catheter was advanced without resistance. The balloon was inflated once and ruptured at the rated burst pressure of 14 atmospheres. Another same size armada 18 was used to complete the procedure. There were no adverse patient effects and no 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# 9616693
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 Key8351736
Report Number2024168-2019-01224
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 02/19/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/19/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1014255-150
Device LOT Number8052841
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 Received02/08/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/01/2018
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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