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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 1013464-200
Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/07/2018
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 was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that during device preparation on the table, the armada dilatation catheter was unable to hold negative pressure and an air leak was assumed. A hole was suspected although not observed. The device was set aside and there was no patient involvement. There was no additional information provided regarding this issue.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual and functional inspection was performed on the returned device. The hub leak was confirmed. 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 indication to suggest that the issue is lot specific. The investigation determined the reported hub leak appears to be related to a potential product quality issue. The issue is being addressed per internal operating procedures. Abbott vascular will continue to trend the performance of these devices.
 
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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
MDR Report Key7310333
MDR Text Key101483422
Report Number2024168-2018-01518
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K151317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Catalogue Number1013464-200
Device Lot Number6081141
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/21/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2018
Is This a Reprocessed and Reused Single-Use Device? No

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