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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 1014256-040
Device Problems Leak/Splash (1354); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/19/2018
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 is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that a 5. 0x40 mm x 90cm armada 18 otw percutaneous transluminal angioplasty (pta) catheter balloon did not perform as expected during a procedure and leakage was observed on the black part [strain relief] at the proximal hub. There was no reported patient effect and no reported clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Visual and functional inspection was performed on the returned device. The reported leak was confirmed. It should be noted that the armada 18 instruction for use (ifu), 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. Additionally, the ifu instructs: carefully inspect the catheter prior to use to verify that it has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used. In this case, the noted ifu violations did not contribute to the leak. The investigation determined the reported leak appears to be related to a potential product quality issue. The issue is being addressed per internal operation procedures. Abbott vascular will continue to trend the performance of these devices.
 
Event Description
Subsequent to the initially filed report, the following information was received: the procedure was performed to treat an 80% stenosed, moderately calcified lesion in the subclavian artery. There was a slow drop in pressure during the first balloon inflation of the armada 18 otw pta catheter, and the same catheter was used to complete the procedure by manually keeping nominal pressure. 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 Key7779368
MDR Text Key117016528
Report Number2024168-2018-06227
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K151317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Catalogue Number1014256-040
Device Lot Number6110241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2016
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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